Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work

How Sarepta And Biogen Are Following The Actimmune Playbook

With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored.

StockWatch_Andy-Smith_V2_1200.jpg
Andy Smith gives a life sciences investor's perspective on biopharma business

I met the management of InterMune Inc. almost 20 years ago when it was a mid-sized US biotechnology company that had three approved products, two of them interferons. Virtually all of InterMune’s revenues came from one product − Actimmune (interferon gamma 1b), originally licensed from Genentech Inc. in 1998. 

Actimmune was approved for two rare congenital disorders, but the vast majority of its sales were off-label in idiopathic pulmonary...

More from Stock Watch

More from Business