Pharma roundup: drug approvals and appraisals

Image of different medicine bottles to show Pharma roundup: drug approvals and appraisals

Pf’s round-up of this week’s drug approvals and appraisals.

UK

The National Institute for Health and Care Excellence (NICE) published the outcome of the appeal against its final draft guidance on erenumab (Aimovig, Novartis) for preventing chronic migraine.

Europe

GSK announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma.

Clovis Oncology announced the availability and reimbursement for Rubraca® (rucaparib) tablets for women with relapsed ovarian cancer in France.

USA

Seqirus announced that the FDA approved AUDENZ™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to help protect individuals six months of age and older against influenza A (H5N1).

MSD announced that the FDA has accepted for review a supplemental New Drug Application for RECARBRIO™ (imipenem, cilastatin, and relebactam) to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms.


Previous approvals and appraisals

Latest pharma drug approvals and appraisals – 31 January 2020

What’s been authorised? UK, Europe, US drug approvals – 24 January 2020