Biotech Stocks Facing FDA Decision In November 2019

trikafta oct28

As another month comes to an end, it's time to take a look back at some of the pharma news stories of October and look ahead at what's coming next over the horizon on the regulatory front.

On October 21, 2019, the FDA approved Trikafta, which is a combination of elexacaftor/ivacaftor/tezacaftor, the first triple combination therapy for patients with the most common cystic fibrosis mutation. Developed by Vertex Pharmaceuticals Inc. (VRTX), Trikafta is indicated for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Eli Lilly and Co.'s (LLY) Reyvow, a new option for the acute treatment of migraine, received the U.S. regulatory nod on October 11, 2019. Reyvow, which is a serotonin 5-HT1F receptor agonist, represents the first new class of acute migraine treatment approved by the FDA in more than two decades.

The first rapid diagnostic test for detecting Ebola virus antigens, OraQuick Ebola Test, was greenlighted by the FDA on October 10, 2019. OraSure Technologies' OraQuick Ebola Test was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type.

The first-ever treatment for erythropoietic protoporphyria, a rare disorder that causes extreme pain to patients when exposed to light, secured FDA approval on October 8, 2019, and it goes by the name Scenesse. Developed by Claudel Pharmaceuticals, Scenesse is administered as a 16mg controlled-release injectable implant, designed to provide protection for up to 60 days.

Now, let's take a look at the pending FDA decisions in November 2019.

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