Dostarlimab, Zynteglo & COVID-19 Combo Drugs In The Spotlight At EMA
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.
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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 company will likely have its answer in a matter of weeks, but a link to the vector would be a “worst-case scenario.”
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.