EU Safety Review Starts For Oral Anticoagulants
The European Medicines Agency is conducting safety reviews of Eliquis, Pradaxa and Xarelto, and is looking at whether the marketing authorization for the anticancer medicine Lartruvo should be maintained. It has also asked manufacturers of angiotensin II receptor blockers to review their manufacturing processes to ensure they do not produce nitrosamine impurities. Meanwhile, manufacturers of omega 3 fatty acid medicines have requested a re-examination of a CHMP recommendation on their products.
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The terms of the marketing authorizations for oral-use omega-3 fatty acid-containing medicines in the EU will have to updated to reflect the fact that they should no longer be used for secondary prevention after myocardial infarction.
The European Medicines Agency’s drug evaluation committee has recommended for approval Teva’s Ajovy for migraine and Pfizer’s Vizimpro for NSCLC, as well as two more biosimilar versions of adalimumab (AbbVie’s Humira) and generics of atazanavir and feboxustat.
The EMA says that in light of the disappointing results of the ANNOUNCE trial, no new treatments should be initiated with Lilly’s Lartruvo in patients with soft tissue sarcoma. This is the first time the agency has taken action such as this on a product that has received a conditional marketing authorization.