Arimoclomol & Ipique Developers To Make Their Case For EU Approval
Orphazyme & Rotterdam Biologics Are Scheduled To Present Before The EMA This Week
The sponsors of two investigational drugs that have previously experienced key regulatory setbacks are set to give oral explanations to the European Medicines Agency about why they believe their products should be approved in the EU.
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Danish biotech Orphazyme has withdrawn the EU marketing application for its Niemann-Pick disease type C therapy arimoclomol and all hopes for the drug’s survival now rest on a meeting with the US Food and Drug Administration.
All hopes for survival rest on a meeting with the US FDA about arimoclomol now that the Danish biotech has withdrawn its submission for the Niemann-Pick disease type C therapy with the European Medicines Agency.
An insomnia drug to improve daytime functioning, a treatment for a rare type of eye cancer, and an oral migraine drug for both acute and preventive treatment are among 13 new products recommended for pan-EU approval.