EMA Reviewing Two MAb Combinations For COVID-19
Products Being Assessed Under Special Procedure For EU Member States
The European Medicines Agency's special review process that was used to help EU member states issue emergency use approvals for dexamethasone in COVID-19 patients is now being applied to two antibody combinations from Regeneron/Roche and Lilly.
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New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
The sponsors of seven new drugs are set to find out this week whether the European Medicines Agency’s human medicines committee, the CHMP, will recommend pan-EU approval for their products. CHMP action is also expected regarding two potential combination therapies for COVID-19.
US FDA's EUA allows lower doses of the two antibodies than were tested in BLAZE-1, which should extend current supply. With Amgen, Lilly hopes to manufacture 1 million doses by mid-year.