EU CHMP

Concizumab sponsor Novo Nordisk and a number of other companies could soon learn whether or not the European Medicines Agency will give their respective drugs the marketing thumbs up.

A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add four new products, including Anzupgo, LEO Pharma's treatment for moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.

The company’s decision to withdraw the drug was based on “the totality of clinical data that now indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.”

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

The European Medicines Agency has recommended the pan-EU approval of three rare disease drugs: Pfizer’s Hympavzi, Henlius Biotech’s Hetronify and ImmunoGen’s Elahere in addition to five other new medicines.

Reliance procedures have been used for most recent new drug approvals, and will continue to be employed in future, although the national approval route will play a key role in promoting innovation and protecting public health, says the UK regulator.

The European Medicines Agency is this week expected to decide whether to recommend for pan-EU marketing approval for Pfizer’s marstacimab, Henlius Biotech’s serplulimab and ImmunoGen’s mirvetuximab soravtansine.

Sugemalimab, from CStone Pharmaceuticals/EQRx, for use in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.