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EU Marketing Setback For Ipsen’s Connective Tissue Disease Drug

 
• By Neena Brizmohun

The European Medicines Agency is standing by its recommendation to reject Ipsen’s EU marketing authorization application for Sohonos, for treating fibrodysplasia ossificans progressiva.

The EMA said the benefits of Sohonos did not outweigh its risks • Source: Shutterstock

Ipsen has failed to convince the European Medicines Agency to reverse its recommendation to refuse pan-EU marketing approval for Sohonos (palovarotene), the company’s orphan drug for the rare genetic disease fibrodysplasia ossificans progressiva (FOP).

The EMA’s human medicines committee, the CHMP, has re-examined the negative opinion it adopted for the product in January and has confirmed that opinion, the EMA said, explaining that it considered that the benefits of the drug did not outweigh its risks

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More from Europe

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
• By Francesca Bruce

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

More from Geography

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.