FDA Action Alert: Merck, Jazz, Regeneron, Sanofi and TherapeuticsMD

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This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi's cancer drug, there are still plenty of other decisions being made this week. Here’s a look.

Merck’s Doravirine for 2 HIV Indications

Merck & Co has a target action date of October 23 for two New Drug Applications (NDA). Both are for doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV-1 infection in adults. One is for doravirine as a once-daily tablet in combination with other antiretroviral agents and the other is for doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose combination single tablet as a complete regimen.

Both NDAs are based on results from two Phase III trials, DRIVE-FORWARD and DRIVE-AHEAD.

Jazz Pharma Looking for Revised Indications for Sleep Medication

Jazz Pharmaceuticals has a target action date for a supplemental new drug application (sNDA) revising labeling for Xyrem (sodium oxybate) to include an indication to treat cataplexy and excessive daytime sleepiness (EDS) in pediatric narcolepsy patients. The PDUFA date is October 27, 2018.

“There has been a great deal of interest from the narcolepsy community in understanding the safety and efficacy of Xyrem in pediatric patients,” stated Jed Black, senior vice president, Sleep and CNS Medicine at Jazz, in a June 2018 statement. “Jazz continues to strive to address unmet needs within the sleep community.”

The drug is indicated for the treatment of cataplexy in narcolepsy and for treatment of EDS in narcolepsy in adults.

Regeneron and Sanofi’s Libtayo (Cemiplimab) Approved

Regeneron and Sanofi had a target action date of the FDA of October 28 for cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC), the deadliest nonmelanoma skin cancer. The drug is a human monoclonal antibody that targets PD-1. The drug is also being reviewed by the European Medicines Agency (EMA), which expects to have a decision in the first half of 2019. However, the FDA approved the drug on September 28 under the brand name Libtayo.

“Today’s FDA decision is great news for patients with advanced CSCC, who previously had no approved treatment options,” stated Michael R. Migden, lead investigator in the pivotal CSCC clinical program and professor in the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center, “Libtayo is an important new immunotherapy option for U.S, physicians to help address a significant unmet need in this patient group.”

TherapeuticsMD’s Menopausal Drug Up for Approval

Boca Raton, Fla,-based TherapeuticsMD has a target action date of October 28 for its TX-001HR. TX-001HR is a bio-identical hormone therapy combination of estradiol and progesterone combined in an oral softgel to treat moderate-to-severe vasomotor symptoms due to menopause. The “vasomotor symptoms” the therapy is supposed to treat is hot flashes.

“The acceptance of the NDA for TX-001HR is another important milestone for TherapeuticsMD and reaffirms the strength and commitment of our organization,” stated Robert G. Finizio, company chief executive officer, in a March statement. “If approved, TX-001HR has the potential to be the first and only combination of bio-identical estradiol and bio-identical progesterone in a single, oral softgel to meet the needs of patients, physicians, and pharmacies as an FDA-approved, third-party reimbursed treatment option for women suffering from moderate-to-severe vasomotor symptoms due to menopause.”

On September 27, the company indicated it had entered into discussions with the FDA over the proposed label for the drug.

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