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Pharma Stock Roundup: FDA Nod for SNY's Pompe Drug & New Use of MRK's Keytruda

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This week, the FDA approved Sanofi’s SNY late-onset Pompe disease drug, Nexviazyme (avalglucosidase alfa) and Merck’s MRK blockbuster PD-L1 inhibitor, Keytruda plus Lenvima for expanded use in kidney cancer. The FDA also approved Jazz Pharma’s JAZZ sleep medicine, Xyway for a new neurologic sleep disorder.

Recap of the Week’s Most Important Stories

FDA Approves Sanofi’s Pompe Disease Drug: The FDA granted approval to Sanofi’s enzyme replacement therapy, Nexviazyme (avalglucosidase alfa), for the treatment of late-onset Pompe disease, a rare degenerative muscle disorder. Nexviazyme targets the M6P receptor, the key pathway for cellular uptake of enzyme replacement therapy. In a phase III study called COMET, Nexviazyme resulted in improvements in respiratory function and walking distance in patients with LOPD.

FDA’s Nod to Merck’s Keytruda for First Line Kidney Cancer: The FDA approved Merck’s Keytruda plus partner Eisai’s Lenvima for the first-line treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. The approval was based on data from the pivotal phase III CLEAR (Study 307)/KEYNOTE-581 study. At present, Keytruda is approved in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of advanced RCC. Moreover, Keytruda plus Lenvima is now approved for two types of cancers, RCC and advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The FDA accepted and granted priority review to Merck’s supplemental biologics license application (sBLA) seeking expanded use of Keytruda for the adjuvant treatment of certain patients with RCC. The FDA’s decision is expected on Dec 10, 2021. This sBLA was based on data from the pivotal phase III KEYNOTE-564 study.

The FDA also accepted another sBLA seeking approval of Keytruda for certain patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial carcinoma. FDA’s decision on this sBLA is expected on Mar 28, 2022. The sBLA is based on data from two cohorts of KEYNOTE-158 study. Keytruda is already approved in combination with partner Eisai’s Lenvima for treating certain patients with endometrial carcinoma that is not MSI-H/dMMR.

FDA Approves Jazz’s Xyway For a New Indication: The FDA approved Jazz Pharma’s Xywav for a new indication — idiopathic hypersomnia (IH) for adults. With the approval for the IH indication, Xywav becomes the first and only FDA-approved treatment for this chronic neurological sleep disorder characterized by excessive daytime sleepiness. The drug is expected to be launched for the IH indication later this year following Risk Evaluation and Mitigation Strategies (REMS) implementation. Xywav, a low sodium formulation of Jazz’s sleep disorder drug, Xyrem, was approved by the FDA in July 2020 for excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients. The drug was launched in November.

Jazz’s newly acquired drug, Epidyolex (cannabidiol) was approved by regulatory authorities of United Kingdom for its third indication — tuberous sclerosis complex (TCS) associated seizures. The drug is already approved in the United Kingdom as an adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) and Dravet syndrome. Epidiolex (brand name of Epidyolex in the United States) is already approved for seizures associated with TSC as well as LGS and Dravet syndrome in the United States. Epidyolex/Epidiolex, a cannabis-based oral solution, was added to Jazz’s portfolio with its acquisition of GW Pharmaceuticals in May this year.

AstraZeneca/Daiichi’s Enhertu Succeeds in Breast Cancer Study: AstraZeneca AZN and Daiichi Sankyo’s antibody drug conjugate (ADC) Enhertu demonstrated superiority over trastuzumab emtansine (T-DM1) in the head-to-head DESTINY-Breast03 phase III study. The Independent Data Monitoring Committee (IDMC) said that the study had met the primary endpoint of progression-free survival (PFS) by showing a highly statistically significant and clinically meaningful improvement in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Though the overall survival (OS - a key secondary endpoint) data are still immature, the study indicated strong trend toward improved OS, compared to T-DM1. Enhertu is already approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens in the metastatic setting based on data from the DESTINY-Breast01 study.

The European Commission granted approval to AstraZeneca’s diabetes medicine, Forxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD) in adults with and without type-II diabetes (T2D). The FDA had approved Farxiga (Forxiga’s brand name in the U.S. market) for the CKD indication in April this year. The approval was based on data from the phase III DAPA-CKD study.

FDA’s Fast Track Tag for Pfizer’s Gene Therapy Candidate: The FDA granted Fast Track status to Pfizer PFE and partner Vivet Therapeutics’ VTX-801, an investigational gene therapy for the treatment of Wilson Disease, a rare and potentially life-threatening liver disorder. VTX-801 will be evaluated in a phase I/II study for which Pfizer will provide the clinical supply. Pfizer and Vivet had signed a manufacturing deal last year

The NYSE ARCA Pharmaceutical Index rose 0.5% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the last five trading sessions.

Zacks Investment Research
Zacks Investment Research


Image Source: Zacks Investment Research

In the last five trading sessions, Pfizer rose the most (4.8%) while AstraZeneca’s stock declined the most (1.6%).

In the past six months, Pfizer has recorded the maximum gain (36%) while Novartis NVS has seen the least gain (0.9%)

(See the last pharma stock roundup here: LLY, NVO, BAYRY Q2 Earnings, SNY’s TBIO Buyout, FDA Updates)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.


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