The FDA was fairly active this week, granting approval for expanded use of Merck’s MRK blockbuster PD-L1 inhibitor, Keytruda and J&J’s JNJ new prostate cancer drug, Erleada. The regulatory agency granted Fast Track status to AstraZeneca’s AZN diabetes medicine, Farxiga for heart failure and Breakthrough Therapy status to Roche’s RHHBY leukemia medicine, Gazyva for lupus nephritis.
Recap of the Week’s Most Important Stories
FDA Approval to Merck’s Keytruda+Lenvima Combo for Endometrial Carcinoma: Merck gained FDA’s accelerated approval for a combination of its cancer medicines, Keytruda and tyrosine kinase inhibitor, Lenvima for the treatment of certain types of endometrial carcinoma. Merck has a deal with Japan’s Eisai to co-develop and commercialize Lenvima, both as a monotherapy as well as in combination with Keytruda, for several types of cancer. The latest approval is the first in the United States for a combination of Keytruda and Lenvima. The approval of Keytruda+Lenvima for women whose endometrial cancer has progressed following prior systemic therapy and whose tumors are not MSI-H or dMMR and who are not candidates for curative surgery or radiation, is an accelerated one. It is based on objective response rate and the duration of response data from KEYNOTE-146 study.
The FDA also accepted Merck’s biologics license application (BLA) for its investigational vaccine for Ebola Zaire disease, V920. Merck filed the BLA on a rolling basis, beginning in November last year. With the FDA granting priority review designation to the BLA, a decision is expected on Mar 14, 2020. A regulatory application is also under review in the EU for V920.
FDA Approval to J&J’s Erleada for New Indication: The FDA granted approval to J&J’s new prostate cancer drug Erleada for expanded use — for the treatment of patients with metastatic castration-sensitive prostate cancer. Erleada is already marketed in the United States for the treatment of men with non-metastatic castration-resistant prostate cancer. The supplemental new drug application was based on data from the phase III TITAN study.
J&J’s subsidiary, Janssen announced submission of a supplemental biologics license application to the FDA, seeking approval to expand the label of its IL-23 inhibitor Tremfya as a treatment for active psoriatic arthritis. The sBLA filing was based on data from the phase III DISCOVER 1 and 2 studies. J&J expects to file a similar regulatory application in the EU by the end of this year.
FDA’s Fast Track Status to AstraZeneca’s Farxiga for Heart Failure: The FDA granted Fast Track designation to AstraZeneca’s SGLT2 inhibitor Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in patients with heart failure with reduced ejection fraction and preserved ejection fraction. The status was granted based on data from the DAPA-HF and DELIVER phase III outcomes studies. Last month, Farxiga was granted the prestigious designation for chronic kidney disease.
FDA’s Breakthrough Therapy Status to Roche’s Gazyva for Lupus Nephritis: The FDA granted Breakthrough Therapy status to Roche’s leukemia medicine, Gazyva, for lupus nephritis, a serious kidney disorder, which is a complication of systemic lupus erythematosus, an autoimmune disease. The prestigious status was based on data from the phase II NOBILITY study, which showed that Gazyva, in combination with standard of care medicines, helped a higher number of lupus nephritis patients achieve a complete renal response than standard of care alone. Roche plans to begin enrolment in a phase III study on the indication in 2020.
Novartis’ Label Expansion Study on Cosentyx Meets Endpoints: Novartis’ NVS phase III PREVENT study evaluating its psoriasis drug, Cosentyx, for its fourth indication, active non-radiographic axial spondyloarthritis (nr-axSpA), met its primary as well as all secondary endpoints. The study met its primary endpoint of ASAS40 at week 16, showing that patients treated with Cosentyx experienced significant and clinically meaningful reduction in disease activity versus placebo. Cosentyx is already approved in the United States and Europe for the treatment of moderate-to-severe plaque psoriasis, AS and psoriatic arthritis.
The NYSE ARCA Pharmaceutical Index rose 0.02% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
Last week, while AstraZeneca rose the most (4%), Pfizer PFE declined the most (2.1%).
In the past six months, AstraZeneca has been the biggest gainer (3.9%) while Pfizer lost the most (13.7%).
(See the last pharma stock roundup here: Pipeline/Regulatory Updates from GSK, PFE & Others
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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