Key FDA Events In June Investors Need To Watch Out For

It has been a busy year for the FDA so far with the agency approving 14 drugs. Key approvals include Novartis’ Lutathera, Gilead Sciences’ HIV regimen, Biktarvy; Vertex Pharmaceuticals’ Symdeko (tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF), Johnson & Johnson’s Erleada for prostate cancer, Amgen’s Aimoviq for the treatment of migraine, BioMarin’s Palynziq for the treatment of phenylketonuria, and Dova Pharmaceuticals Doptelet among others.

The approval of these drugs should boost their respective companies’ top line as a few of them are struggling with decline in sales of legacy drugs.  

Meanwhile, the spotlight is on the “right-to-try” law as President Trump recently signed the bill that enables drug regulators to allow terminally ill patients access to experimental drugs into law. Per this law, patients with life-threatening conditions can now ask drugmakers for drugs that have cleared some testing but have not been approved by the FDA yet.  

With the drug development process being a lengthy one and requiring a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of June.

Will New Drug Approvals Boost Valeant?

Valeant Pharmaceuticals VRX has a few PDUFA dates in the remainder of 2018. Among these, the one in June is for IDP-118. The FDA had accepted the new drug application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an experimental topical treatment for plaque psoriasis in November 2017 and set a PDUFA action date of Jun 18, 2018.

Valeant is banking on approval of new drugs to boost its lagging dermatology business. Per the company, IDP-118 will be the first and only topical lotion with a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, thus extending the duration of use.

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