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Key FDA Events in June Investors Need to Watch Out For

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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 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.

The FDA had earlier approved Siliq for psoriasis. The company also obtained FDA approval for Vyzulta, a treatment option for glaucoma. The FDA also approved Lumify, the over-the-counter eye drop with low-dose brimonidine for the treatment of eye redness.

Valeant currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GWPH’s Epidiolex Awaits FDA Nod

GW Pharmaceuticals plc (GWPH - Free Report) completed a rolling submission of a NDA for an investigational cannabidiol oral solution (CBD), also known as Epidiolex, for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome (LGS) to the FDA on Oct 27, 2017. The agency set a PDUFA goal date of Jun 27, 2018.

A FDA approval is likely as the Peripheral and Central Nervous System Drugs Advisory Committee unanimously recommended the approval of the NDA.

An approval would be a significant boost for the company. Assuming approval, Epidiolex would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).


Keytruda’s Label Expansion for Cervical Cancer

Merck’s (MRK - Free Report) blockbuster drug, Keytruda’s supplemental Biologics License Application (sBLA) for the treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy is under FDA review and the agency will decide on the same on Jun 28, 2018 on a priority review basis.

Merck’s blockbuster immuno-oncology drug, Keytruda is already approved for a variety of cancers — metastatic non-small cell lung cancer (NSCLC), recurrent or metastatic head and neck squamous cell carcinoma, metastatic urothelial carcinoma, and gastric cancer among others.
Approval for cervical cancer will further boost sales of the drug.

Array Biopharma Combo Drug to Get Approval?

Array Biopharma’s (ARRY - Free Report) NDAs to support use of experimental encorafenib and binimetinib combination for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma is under FDA review and the agency has set a target action date of June 30, 2018.

The company had previously announced that treatment with the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450) reduced the risk of death compared to treatment with vemurafenib 960 mg daily in patients with BRAF-mutant melanoma in the phase III COLUMBUS trial.

Apart from these, the FDA will also decide on the future of a few other drugs like –  Alkermes’ (ALKS - Free Report) NDA for Aripiprazole Lauroxil NanoCrystal Dispersion and Achaogen’s (AKAO - Free Report) plazomicin among others.

Hence, investors are expected to keep a close watch on the FDA’s actions this month.

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