FDA Action Alert: Ortho Dermatologics, Tetraphase Pharma, Akcea and More

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This week has several action dates by the U.S. Food and Drug Administration (FDA) for a range of indications, including acne, intra-abdominal infections, and rare liver diseases. Here’s a look.

Bausch Health Companies’ (formerly Valeant Pharmaceuticals) Ortho Dermatologics division has a PDUFA action date of Monday, August 27, 2018, for its New Drug Application (NDA) for Altreno. Altreno, if approved, will be the first tretinoin product in lotion form instead of a gel or crème. Altreno is a treatment for acne.

“More than 4 million patients make appointments with dermatologists each year or acne,” said Joseph Papa, Valeant chairman and chief executive officer, in a statement in January. “It is our goal to be the go-to resource for doctors and patients for all dermatological conditions, and if approved, Altreno will be a valuable addition to the Ortho Dermatologics portfolio.”

TetraPhase Pharmaceuticals has a PDUFA date for its NDA for eravacycline for complicated intra-abdominal infections (cIAI). The NDA submission included data from IGNITE1 and IGNITE4 Phase III clinical trials, which compared twice-daily IV eravacycline to ertapenem in IGNITE1 and meropenem in IGNITRE4. Eravacycline is a novel, fully-synthetic fluorocycline antibiotic developed to treat cIAI and other serious infections, including infections caused by multidrug-resistant (MDR) pathogens.

“The FDA’s acceptance for review of our NDA submission for IV eravacycline in cIAI marks an important step in our goal to bring this important new treatment option to patients in need,” said Guy Macdonald, Tetraphase’s president and chief executive officer, in a statement in February. “We believe that eravacycline has the potential to play a key role in the treatment of serious intra-abdominal infections, particularly Gram-negative infections, and we look forward to providing an update on a regulatory decision in August as we continue to prepare for a commercial launch.”

On July 27, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) reported a positive opinion recommending Xerava (eravacycline) for approval for cIAI. A decision should be made by the end of November by the EMA.

Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, has a PDUFA target date of August 30, 2018, for Waylivra (volanesorsen) for patients with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease characterized by extremely high triglyceride levels and symptoms such as extreme abdominal pain. There is also a risk of recurrent, potentially fatal, acute pancreatitis.

The same time the NDA was accepted for review by the FDA, it was accepted by the EMA and Canada’s regulatory agency, Health Canada. Health Canada gave it Priority Review and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted it a Promising Innovative Medicine (PIM) Designation.

“We are committed to seeking global approvals for volanesorsen at the outset,” said Paula Soteropoulos, Akcea’s chief executive officer, in a November 2017 statement. “The acceptances of our regulatory filings in the U.S., EU and Canada are important steps forward in the global regulatory review process for volanesorsen, which brings us closer to potentially providing the first approved therapy for the treatment of people with FCS.”

The drug is designed to decrease the production of ApoC-III, a liver protein that’s involved in the regulation of plasma triglycerides. It is also under development for FPL, another severe, rare genetic metabolic disorder characterized by the body’s inability to store fat in normal locations. Individuals with FPL are at increased risk of acute pancreatitis as well as long-term, progressive diseases such as premature cardiomyopathy, atherosclerosis, and liver disease.

It was announced on August 2 that Akcea and PTC Therapeutics were collaborating to commercialize two of Akcea’s drugs in Latin America, Tegsedi (inotersen) and Waylivra. Tegsedi has a PDUFA date of October 6, 2018, for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR amyloidosis).

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