FDA Action Alert: Sage, Jazz, Lexicon and Sanofi, AMAG Pharma, and Recro Pharma

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It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.

Sage Therapeutics’ Zulresso for Postpartum Depression

Cambridge, Mass.-based SAGE Therapeutics has a target action date of March 19 for its Zulresso (brexanolone) to treat postpartum depression (PPD). Originally the PDUFA date was December 19, 2018, but the FDA extended the date. Sage had submitted a proposed Risk Evaluation and Mitigation Strategies (REMS) program with Elements to Ensure Safe Use (ETASU) in response to the agency’s request, which resulted in the extension.

If approved, the drug is expected to be scheduled by the U.S. Drug Enforcement Administration (DEA), consistent with other approved GABAergic drugs. The DEA is then required to issue an interim final rule controlling the drug within 90 days of approval. As a result, that date has also been pushed back, assuming the FDA approves the drug, until June 2019.

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Jazz Pharmaceuticals and Its Solriamfetol for Narcolepsy or Sleep Apnea

Jazz Pharmaceuticals, headquartered in Dublin, has a target action date of March 20 for solriamfetol to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA). This was also a three-month extension from the original PDUFA date. The agency decided that the original New Drug Application (NDA)’s draft labeling need enough revision to be a major amendment.

At the time of the extension, Jed Black, senior vice president, Sleep and CNS Medicine for Jazz, stated, “We appreciate the opportunity to work with the FDA to complete the review process as soon as possible. We are committed to addressing unmet needs in sleep medicine and look forward to offering solriamfetol as a meaningful treatment option for patients living with excessive daytime sleepiness associated with narcolepsy or OSA.”

Lexicon Pharmaceuticals and Sanofi’s Zynquista for Type 1 Diabetes

Lexicon Pharmaceuticals, based in The Woodlands, Texas, and Paris-based Sanofi, have a target action date of March 22 for Zynquista (sotagliflozin) to treat type 1 diabetes. The drug is an oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence glucose absorption in the intestines and kidneys. The NDA was built on data from the inTandem clinical trial program of three Phase III clinical trials in about 3,000 adults in poorly controlled type 1 diabetes. The drug is also being evaluated by the European Medicines Agency (EMA). On Jan. 17, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted eight to eight on the drug’s overall benefits outweighing the risks.

“After decades of little change and innovation, the treatment of type 1 diabetes has begun to shift significantly, and if approved, our dual SGLT-1 and SGLT-2 inhibitor, Zynquista, will be the first approved oral therapy used in combination with insulin to improve glycemic control and patient outcomes for adults in the United States who are living with type 1 diabetes,” stated Pablo Lapuerta, executive vice president and chief medical officer of Lexicon.

AMAG Pharmaceuticals’ Vyleesi for Hypoactive Sexual Desire Disorder

AMAG Pharmaceuticals, headquartered in Waltham, Mass., has a target action date of March 23 for its NDA of Vyleesi (bremelanotide) to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. The drug was in-licensed from Palatin Technologies in February 2018. Bremelanotide is a first-in-class melanocortin 4 receptor agonist. HSDD is the most common form of female sexual dysfunction, affecting about 6 million premenopausal women in the U.S It is noted for persistent low libido associated with distress.

The NDA acceptance triggered a $20 million milestone payment to Palatin under the licensing agreement. If approved, the drug will be the first and only as-desired pharmacologic approved in the U.S. for HSDD in premenopausal women.

Update: AMAG Pharmaceuticals announced earlier this year that bremelanotide’s PDUFA date has been pushed back – from March 23, 2019, to June 23, 2019. 

Recro Pharma’s Intravenous Meloxicam for Moderate to Severe Pain

Malvern, Penn.-based Recro Pharma has a target action date of March 24 for its NDA for intravenous meloxicam for moderate to severe pain. The NDA was resubmitted in September 2018 in response to a Complete Response Letter (CRL) the FDA submitted in May 2018. The CRL indicated that data from ad hoc analyses and selective secondary endpoints suggested the analgesic effect of the formulation did not meet the agency’s expectations. There were also CMC-related questions about extractable and leachable data provided.

Meloxicam is a long-acting, preferential COX-2 inhibitor. The IV formulation uses the NanoCrystal platform, which enables enhanced bioavailability of poorly water-soluble drugs.

“The FDA’s acceptance of the Complete Response to the CRL through the resubmitted NDA for IV meloxicam and the assignment of a PDUFA goal date of March 24, 2019 is important progress for Recro,” stated Gerri Henwood, Recro’s president and chief executive officer, in October 2018. “We remain committed to working closely with the FDA toward an approval decision for IV meloxicam, with the ultimate goal of bringing this novel, non-opioid treatment option to patients and physicians for the management of moderate to severe pain.”

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