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Merck & Other Pharma Players Await FDA Decisions in October

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In the United States, there has been a huge increase in FDA approvals for cancer and rare- to-treat diseases’ drugs, thanks to efficient and effective regulatory processes. The FDA has already approved 41 novel drugs till September. Last year, the FDA had given nod to 34 new drugs till September and approved 46 drugs in the full year.

The 46 drug approvals last year were the highest number of drugs approved by the FDA in more than a decade. Looking at the trend this year so far, it appears that the number of drug approvals will easily surpass 2017’s tally. With President Trump supporting streamlined FDA policies with an expedited drug approval process, innovation has picked up pace in the sector, thus increasing the possibility of approvals.

Landmark decisions this year so far include J&J’s (JNJ - Free Report) Erleada (apalutamide) for pre-metastatic prostate cancer; Vertex Pharmaceuticals’ cystic fibrosis (CF) medicine Symdeko; Amgen (AMGN - Free Report) /Novartis (NVS - Free Report) , Eli Lilly (LLY - Free Report) and Teva Pharma’s (TEVA - Free Report) calcitonin gene-related peptide (CGRP) migraine treatments, Aimovig, Emgality and Ajovy respectively; AbbVie’s (ABBV - Free Report) Orilissa for pain associated with endometriosis; Merck’s (MRK - Free Report) two new HIV drugs — Pifeltro and Delstrigo; and BioMarin Pharmaceuticals’ Palynziq to treat phenylketonuria (PKU).

The drug development process is lengthy and requires a lot of funds and resources. Consequently, pipeline events including data readouts and regulatory updates act as major catalysts.



Let’s take a look at a few important regulatory events scheduled for the month of October.

FDA Decision on Merck’s Keytruda for a Difficult Lung Cancer: On Oct 30, the FDA is expected to give its decision on Merck’s sNDA seeking label expansion of Keytruda, in combination with chemotherapy, as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC)— a difficult-to-treat lung cancer patient population. The sNDA filing was based on data from the phase 3 KEYNOTE-407 study.

Data from the study presented at ASCO showed that the combination of Keytruda plus chemotherapy led to significant improvement in both overall survival (OS) and progression-free survival regardless of PD-L1 expression. The data was termed “practice changing” by CNBC – changing the way doctors look at prescribing these drugs to cancer patients. If Merck gets approval for this label expansion, it will further cement its position in the lung cancer market, which is the most lucrative oncology sector.

New Indication for Regeneron/Sanofi’s Dupixent: On Oct 20, the FDA is expected to give its decision on Regeneron/Sanofi’s supplemental biologics license application (sBLA) for label expansion of its eczema drug, Dupixent for a new indication – as an add-on maintenance treatment of adults and adolescents with moderate-to-severe asthma.

Dupixent is already approved for the treatment of atopic dermatitis (AD) or eczema. Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases such as nasal polyposis, eosinophilic esophagitis and grass immunotherapy.

Approval of Roche’s and Jazz Pharmaceuticals’ Drugs in Expanded Patient Populations: This week, a decision is expected on Roche’s sBLA seeking approval of its drug Hemlibra for treatment of hemophilia A patients without factor VIII inhibitors. Hemlibra is presently marketed for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A patients with factor VIII inhibitors.

On Oct 27, the FDA is expected to give its decision on Jazz Pharmaceuticals’ sNDA, looking for approval of its key drug Xyrem in pediatric patients for the treatment of cataplexy and excessive daytime sleepiness (EDS) in narcolepsy patients.

Ionis Pharma’s Tegsedi and Therapeutics MD’s TX-001HR Await FDA Nod: The FDA will give its decision on Akcea Therapeutics and Ionis Pharmaceuticals’ Tegsedi (inotersen) on Oct 6. Tegsedi has been developed for the treatment of hereditary TTR amyloidosis (hATTR), an inherited, progressive and fatal disease with limited treatment options. Tegsedi was approved in the European Union in July this year.

On Oct 28, the FDA is expected to give its decision on TherapeuticsMD’s pipeline candidate TX-001HR, a bio-identical hormone therapy combination of estradiol and progesterone. TherapeuticsMD is seeking approval of TX-001HR as a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

FDA Approval of Bausch Health’s Jemdel Lotion Due: On Oct 5, the FDA is expected to give its decision on Bausch Health Companies’ high-potency topical steroid treatment, Jemdel for plaque psoriasis.

Stay Tuned for Additional Updates

Some key FDA decisions expected in the near term include Acorda Therapeutics’ Inbrija for treating OFF periods in patients with Parkinson’s disease (PD), Sanofi’s sotagliflozin for type I diabetes, Alexion’s ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria and Jazz Pharmaceuticals’ solriamfetol for excessive sleepiness in narcolepsy & obstructive sleep apnea among others. Hence, investors are expected to keep a close watch on the FDA’s actions in the next few months

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