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LES ULIS, France--(BUSINESS WIRE)--LFB today announced that the European Medicines Agency (EMA) has granted on July 15th a Marketing Authorisation for CEVENFACTA (eptacog beta), as the first new bypassing agent in over 20 years. CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:

Denis Delval, LFBs Chairman and Chief Executive Officer, stated: We are very pleased with the approval of CEVENFACTA by the EMA, which provides a new treatment option for haemophilia patients with inhibitors in the European Union. This approval is a validation of our innovative LFB technology and the acknowledgement of LFBs deep commitment to patients.

Dr. Patrick Delavault, MD, LFBs Executive Vice President Scientific, Medical and Regulatory Affairs, stated: We need to keep in mind constantly what a bleeding event, even a single bleeding event, means to a haemophilia patient with inhibitors and to his family. This novel treatment alternative is a significative opportunity to improve patients lives.

LFB has been granted a Marketing Authorisation for SEVENFACT (eptacog beta) in Mexico on June 2nd for the treatment of bleeding episodes in adults and adolescents with haemophilia A or B with inhibitors.

About PERSEPT studies:

The approval of CEVENFACTA was based on data from the phase III clinical trials, PERSEPT 1 and PERSEPT 3.

The PERSEPT 1 Phase III, multicentre, randomised, open-label crossover study of two initial dose regimens (75g/kg and 225g/kg), evaluated 468 bleeding episodes across the full type of severity of bleeding episodes (mild, moderate, and severe), in 27 adolescent and adult haemophilia A and B patients with inhibitors (12-54 years of age). Both dosing regimens met the primary endpoint with 81% and 90% of bleeds controlled at 12 hours with the 75g/kg dose and the 225g/kg dose respectively. By 24 hours, haemostatic efficacy (secondary endpoint) was retained in 96.7% of bleeding episodes treated with the 75 g/kg dose regimen and 99.5% of redundancy bleeding episodes treated with the 225 g/kg dose, without requiring any alternative therapy. The median time to attain haemostatic efficacy was 5.98 hours for the 75 g/kg dosing regimen and 3 hours for the 225 g/kg dosing regimen. A median of 2 injections was needed to treat a bleeding episode with the 75 g/kg and a median of only 1 injection of the 225 g/kg dosing regimen was needed.

The PERSEPT 3 Phase III, multicentre, open-label, single-arm study evaluated the safety and efficacy of CEVENFACTA in haemophilia A or B patients with inhibitors who were scheduled for an elective surgical or other invasive procedure. 12 patients were enrolled in the study, 6 with minor procedures and 6 with major procedures. For major surgical/invasive procedures, treatment was administered at an initial bolus dose of 200 g/kg immediately before the start of the invasive procedure. For a minor elective surgical procedure, an initial bolus dose of 75 g/kg was administered immediately before the start of the procedure. Overall, 81.8% of procedures were reported as successfully treated at 48 hours after the last administration of the product.

No thromboembolic events were reported in these two clinical trials. No Serious Adverse Events (SAEs) were considered as related to the treatment.

Patients should be monitored for any signs of thrombosis, hypersensitivity and neutralising antibodies. The most frequently reported adverse reactions in studies were infusion site discomfort, infusion site haematoma, post-procedural haematoma, infusion related reaction, increased body temperature, dizziness and headache.

About LFB

LFB is a bio-pharmaceutical group that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases. LFB was founded in 1994 in France and is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with blood-derived therapeutics with the vision to provide treatment options to patients in three major areas: immunology, haemostasis, and intensive care.

LFB currently markets 15 biomedicinal products in more than 30 countries.

Please visit http://www.groupe-lfb.com for further information on LFB.

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LFB Announces the Approval of CEVENFACTA (eptacog beta) in the European Union - Business Wire

European Union flags flutter outside the EU Commission headquarters in Brussels, Belgium June 17, 2022. REUTERS/Yves Herman/File Photo

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BRUSSELS, July 22 (Reuters) - The European Commission gave Hungary a final month to address its concerns about the rule of law before asking European Union governments to suspend some of the funds Hungary is to get under the bloc's 2021-2027 budget.

The new deadline is part of an EU process, called the "conditionality mechanism", meant to protect the EU's financial interests against breaches of rule of law by an EU government. It is separate from other procedures over the rule of law that the EU has launched against Hungary.

The Commission believes EU money is at risk in Hungary because of what it says is corruption, which can take the form of tenders for EU funded projects in which only one bidder, usually linked to the ruling party, takes part.

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The EU executive also has concerns about the independence of the judiciary, media and non-governmental organisations.

Hungarian Prime Minister Viktor Orban has in the past dismissed EU and U.S. concerns over corruption in Hungary, but top Hungarian officials have said over the past weeks Budapest was willing to work with the Commission to address the concerns.

Hungary offered this week to cut the number of public tenders in which only one bidder participates to 15% of the total. It has also offered to allow courts to order prosecutors to pursue cases even if prosecutors had decided not to and to make law-making in Hungary more transparent and inclusive.

Because of its concerns over EU budget money, the Commission launched the "conditionality mechanism" against Hungary in April. In the end, it could lead to the suspension of the 21 billion euros ($21.3 billion) for Hungary in the EU budget.

The Commission said on Friday it had mandated Budget Commissioner Johannes Hahn to inform Budapest of the measures that the EU executive intends to propose to EU governments if Hungary's remedial measures are not adequate.

"Hungary has now one month within which it can submit its observations and any additional information, in particular on the proportionality of the measures envisaged by the Commission," the EU executive arm said.

It added Hungary still had the opportunity to submit adequate remedial measures.

The funds affected are known as cohesion funds - which EU countries that are poorer than the EU average get to develop their infrastructure such as roads and bridges, water treatment plants or transportation.

A senior EU official, who asked not to be named, said the Commission's proposal to EU governments would most likely not concern all of the cohesion funds for Hungary, because it had to be proportional to the scale of the problem.

"But it will be a serious proposal, not a symbolic one," the official said.

The suspension of the cohesion funds, however, coming on top of 5.8 billion euros of recovery fund grants that are still frozen, would be a major blow to the Hungarian economy which is suffering from a weakening currency, rising costs of borrowing, a widening budget deficit and rampant inflation.

($1 = 0.9848 euros)

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Reporting by Jan StrupczewskiEditing by Philip Blenkinsop and Frances Kerry

Our Standards: The Thomson Reuters Trust Principles.

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EU gives Hungary a month to act before moving to suspend funds - Reuters

Following the previous legal proceedings filed by the European Commission against the United Kingdom, four more legal proceedings were launched. This time, the suits were in response to the passage of a Northern Ireland bill from the British parliaments lower chamber.

The European Commission filed four additional legal proceedings against the United Kingdom Friday last week. The new legal proceedings came after the House of Commons passed the legislation that would scrap some of the regulations over post-Brexit trade with Northern Ireland.

The European Commission cited the UKs unwillingness to engage in dialogue over the protocol that makes up the arrangements for trade with Northern Ireland in its new legal proceedings. The passage of the legislation that would scrap some of the arrangements by the House of Commons also undermined cooperation, according to the EU.

The four new suits bring the total to seven filed by the European Union against the UK over what it deems is a failure to respect the post-Brexit trade agreement with Northern Ireland.

This could lead the European Court of Justice to impose fines. However, this may not happen for at least a year. The Commission also said it is prepared to launch additional legal procedures to protect the EUs single market from the UKs violations of the protocol.

A legal dispute is in nobodys interest and will not fix the problems facing the people and businesses of Northern Ireland. The EU is left no worse off as a result of the proposals we have made in the Northern Ireland Protocol bill, a spokesperson for the British government said in response to the four new legal proceedings.

Thursday last week, the European Union has imposed sanctions on 10 Syrians accused of enlisting Russian mercenaries as part of its widening sanctions on Russia for its invasion of Ukraine that began in February.

The new additions were part of the blocs new sanctions against Moscow, which targeted lender Sberbank as well as a ban on Russian gold imports, additional companies and individuals, and increased export controls.

The Syrian regime provides support, including military support, for Russias unprovoked and unjustified war of aggression against Ukraine, an EU official said Thursday.

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European Union files additional legal proceedings against UK over Northern Ireland bill - EconoTimes

EU looks to replace gas from Russia with Nigerian supplies

The European Union is seeking additional gas supplies from Nigeria as the bloc prepares for potential Russian supply cuts, Matthew Baldwin, deputy director general of the European Commission's energy department, said on Saturday.

Baldwin was speaking in Nigeria where he held meetings with officials from Africa's largest oil producer this week.

He was told that Nigeria was improving security in the Niger Delta and planned to re-open the Trans Niger pipeline after August, which would yield more gas exports to Europe.

The EU imports 14 per cent of its total LNG supplies from Nigeria and there is potential to more than double this, Baldwin told Reuters by phone.

Oil and gas output in Nigeria is being throttled by theft and vandalism of pipelines, leaving gas producer Nigeria LNG Ltd's terminal at Bonny Island operating at 60per cent capacity.

"If we can get up to beyond 80%, at that point, there might be additional LNG that could be available for spot cargoes to come to Europe," Baldwin said.

"They (Nigerian officials) said to us, 'Come and talk to us again at the end of August because we think we can deliver real progress on this'."

Nigeria NLG is owned by state-oil company NNPC Ltd, Shell, TotalEnergies and Eni.

The European Commission said on Wednesday that EU member states should cut their gas use by 15per cent from August to March. The target would initially be voluntary, but would become mandatory if the Commission declared an emergency.

Last year, Nigeria exported 23 billion cubic metres (bcm) of gas to the EU, but the figure has been declining over the years. In 2018 the bloc bought 36 bcm of LNG from Nigeria, Baldwin said.

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European Union Seeks To Replace Russian Gas With Nigerian Supplies - NDTV Profit

The European commission is taking legal action against Hungary at the European court of justice (ECJ), escalating a longstanding dispute over the countrys anti-LGBT laws. This is an unprecedented step for the EU, but it isnt a sure win for LGBT rights in Europe and even has the potential to endanger them.

Hungary (under Prime Minister Viktor Orbns leadership) and the EU have been at odds for years over the wider issue of the rule of law. This intensified in 2021 when Hungary adopted a new law banning the depiction or promotion of LGBT-related material to minors. Commission president Ursula von der Leyen called it a shame that goes against all the fundamental values of the European Union.

In July 2021, the commission launched official infringement procedures against Hungary for failing to implement and comply with EU law. Later in the year, it also froze Hungarys access to the COVID recovery fund. Unsatisfied with Hungarys responses, the commission has now escalated the matter and referred the matter to the ECJ. This is the first time the EU has taken a member state to court over LGBT rights.

In recent decades, Europe has seen an increase in the use of homophobia to score political points. Examples include the manif pour tous demonstrations against same-sex marriage in France, and Croatias referendum to constitutionally define marriage as a heterosexual union. Hungarys law has also inspired other countries, like Romania, to try and ban so-called homosexual propaganda.

The outcome of this case could have far-reaching consequences for LGBT rights in Europe. In effect, the commission is asking the court to enshrine LGBT rights as part of the EUs fundamental values, on a par with other principles such as freedom of movement.

Perhaps by taking legal action, the commission is enacting its own LGBTIQ equality strategy, launched in 2020. However, the commissions claims frame the case as a breach of the EUs internal market rules, rather than LGBT rights. This should not come as a surprise the EU has very few direct laws on LGBT rights. By framing the case around core EU rules, the commission has a stronger chance of succeeding. In the past, the court has ruled on LGBT rights by invoking other fundamental EU principles.

The EU claims that by enacting this law, Hungary is violating both the EU charter of fundamental rights and Article 2 of the Treaty on European Union.

Here is where the case becomes interesting. Although the charter of fundamental rights has clauses that explicitly protect against discrimination based on sexual orientation, it only applies to Hungary when it is implementing EU directives. Article 2, on the other hand, has much broader applicability, but does not refer to LGBT rights at all. By submitting this court case to the ECJ, the commission is not only asking the court to determine when EU rules have primacy over member state rules but also to clarify that the rather ambiguously defined European values explicitly include LGBT rights.

There are three possible outcomes of this case.

First, the ECJ could rule (for the first time) that the values outlined in Article 2 of the Treaty on European Union also include LGBT rights. This would be the more activist ruling going beyond established case law for a more political statement. Hungary would then be required to adjust the law and remove its discriminatory nature. More widely, this would also be a watershed moment in European LGBT politics it would not only provide a strong mandate for the commission to take bolder steps on LGBT rights, but it might also lead to more challenges of discriminatory laws across Europe.

Second, in a (unlikely) doomsday scenario, the ECJ could side with Hungary. This would provide nearly free rein for anti-LGBT actors in Hungary, and across the EU more widely, to enact more homophobic laws. This would leave the gains made in the last 50 years for LGBT people in Europe on shaky ground.

Finally, in the most likely scenario, the ECJ would deliver a ruling that sits somewhere in between. Based on previous case law, we might expect that the ECJ would rule that the Hungarian law violates EU rules, but only to the extent where the law has cross-border implications. In this scenario, the ECJ ruling would signal to Hungary (and other countries) that is it acceptable to discriminate against homosexuality, as long as they are smart in their wording.

Such a ruling would not clearly and unequivocally clarify that LGBT equality is a fundamental EU value, but rather leave LGBT rights as a secondary principle, subject to the more established EU principles of the internal market and freedom of movement. This would create ambiguity as to when homophobic laws are a matter of member state policy, or when the EU has to (or can) intervene, giving homophobic governments license to enact more laws like Hungarys.

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EU sues Hungary over anti-gay law what it could mean for LGBT rights in Europe - The Conversation