Amryt Due For Oral Explanation At EMA For Epidermolysis Bullosa Gel Filsuvez
Capmatinib Developer May Also Make Its Case Before The CHMP
Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.
You may also be interested in...
CEO Joe Wiley has said the backing of the EMA's advisory committee for its epidermolysis bullosa gel represents "the most significant milestone in Amryt’s history" and is a massive boost for the Dublin-headquartered group after getting a complete response letter in the US a couple of months ago.
PTC Therapeutics’ gene therapy, eladocagene exuparvovec, and Sanofi’s enzyme replacement therapy, olipudase alfa, are among the latest products that the European Medicines Agency is considering for potential marketing approval.
The EMA is poised to say whether or not six new drugs are on track for pan-EU approval, including Janssen’s first cell therapy and an antibody combination to prevent COVID-19 in people with poor immune response.