This week in pharma:
On Tuesday, March 19, the FDA approved the first postpartum depression drug brexanolone (Zulresso—Sage Therapeutics). The $34,000 one-time infusion drug will require a REMS program and has a black box warning of loss of consciousness events and extreme sedation. Another downside of this medication is a 60-hour continuous IV infusion, which would separate mothers from their babies for a significant amount of time. Sage’s chief business officer Mike Cloonan said that the drug will need a “provider champion” to advocate for the product and treating postpartum depression. RBC Capital Markets analyst Brian Abrahams predicts peak sales of $370 million.
FiercePharma ranks pharma’s 2019 blockbuster launches with AbbVie’s rheumatoid arthritis medication upadacitinib at the top of the list, which is expected to be approved in August. Second ranks Novartis’ Zolgensma, which is a pricy gene therapy drug intended to cure spinal muscular atrophy. Third is Astrazeneca and FibroGen’s roxadustat which treats anemia related to chronic kidney disease.
The FDA announces that Abbvie and Roche’s drug Venclexta doubles the risk of death and put the clinical trial on hold. Abbvie and Roche were counting on this myeloma drug to be a key revenue generator and are working with the FDA and worldwide regulatory agencies to determine their next steps.
A new patent settlement gives Novo Nordisk at least four more years to improve their pipeline for diabetes drug in order to compete with Teva’s generic Victoza. Novo currently has an oral formulation of Ozempic, a weekly GLP-1 drug, in their pipeline and is hoping for approval by the end of this year. Novo is also fighting for a pediatric exclusivity from the FDA which may push the expiration back to June 2024.
Bayer pioneers a digital health start-up initiative by collaborating with specific digital health focus areas such as AI for discovery and patient engagement platforms. They aim to speed up innovative solutions and help entrepreneurs grow their companies faster. The programs Accelerator, Dealmaker, and Generator are merging to form the G4A Partnership to give start-ups initial funding and payments for milestone achievements.