There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
Evoke Pharma’s Gimoti Runs Into Trouble
Evoke Pharma’s Gimoti has a target action date of April 1. On March 4, the Solana Beach, Calif.-based company received a multi-disciplinary review (DR) letter from the FDA in association with its New Drug Application (NDA) for Gimotti. A DR letter is used by the FDA to communicate its early thinking on deficiencies observed in an initial review of an NDA. Gimotti is designed to treat gastroparesis, a debilitating, episodic condition characterized by slow or delayed gastric emptying of the stomach after meals, often resulting in symptom flare-ups that include nausea, vomiting, abdominal pain and bloating. It occurs disproportionately in adult women.
There were three sections of the NDA that the agency had concerns about. They were chemistry, a combination of product quality control and reproducibility connected to the commercially available sprayer device used with the drug; clinical—lack of enough data to support sex-based efficacy differences; and clinical pharmacology, specifically that the maximum concentration wasn’t within the parameters of the bioequivalence for abbreviated NDAs.
In theory, the DR letter doesn’t reflect a final FDA decision, but it does throw the April 1 target action date into a cloud of uncertainty.
On March 14, Evoke submitted a response to the DR and requested a meeting with the agency over the April 1 target action date. The meeting was held on March 21, but at this time no information has been released about the content of that meeting.
IntelGenx’s Rizaport for Acute Migraine
Saint Laurent, Quebec-based IntelGenx Corp. has an April 1 target action date for the resubmitted NDA for Rizaport, a VersaFilm oral soluble film to treat acute migraines. The company has five inspectional observations from a January Pre-Approval Inspection as part of the company’s Health Canada-certified cGMP manufacturing facility in Montreal by the FDA. At the time, Horst G. Zerbe, president and chief executive officer of IntelGenx said, “We appreciate the thoroughness of the FDA’s review of our facility, and we are confident that we will be able to address the FDA’s observations within the 15-day response timeframe.” As we continue to advance through the NDA process, IntelGenx is excited to have completed another important milestone toward U.S. approval.”
Rizaport is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt.
ADMA Biologics’ Resubmission of Bivigam
ADMA Biologics, headquartered in Ramsey, NJ, has a target action date of April 2 for Bivigam for the treatment of Primary Immunodeficiency Disease (PIDD). PIDD is a class of inherited genetic diseases that result in a deficient or absent immune system. The FDA issued a Complete Response Letter (CRL) on December 19, 2018 for Bivigam. On January 7, 2019, ADMA submitted its response and provided supplemental information.
Bivigam is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency. That includes agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. Bivigam holds a broad range of antibodies similar to those observed in normal human plasma. The antibodies are directed against bacteria and viruses, and help protect PIDD patients against serious infections.
