US FDA approval tracker: October 2019

It was a case of tales of the unexpected last month with the early approval of Vertex’s triplet Trikafta. The cystic fibrosis drug is the most valuable product to get the nod in October, according to EvaluatePharma, which puts its NPV at $17bn. However, controversies remain over Trikafta’s pricing: at $311,000 per patient per year it is 6% and 14% above the cost of Vertex's older cystic fibrosis doublets Symdeko and Orkambi respectively. Meanwhile, Novartis has set the price for its now-approved eye drug Beovu about in line with the established age-related macular degeneration therapy Eylea. However, the Swiss group might find it hard to take market share from the Regeneron and Bayer megablockbuster, especially as there are concerns about intraocular inflammation with Beovu. Biogen also received the thumbs up for its Tecfidera follow-on, Vumerity, but will now need to move patients onto the new drug before Tecfidera generics hit. Two key patent challenges are approaching, with a district court hearing due in December and an inter partes review set for February.