5 Biotechs Awaiting FDA Decisions in January 2018

From 1997 through 2013, there was an average of 27 novel drugs approved in the U.S. per year. This year, 46 drugs were approved by the U.S. Food and Drug Administration (FDA).That makes 2017 the second-best year for FDA approvals since 1996, when the agency approved 53 novel drugs.

Here are five companies looking at possible drug approvals in January 2018.

1. Lipocine

Headquartered in Salt Lake City, a panel will vote on Jan. 10, 2018 whether to recommend Tlando, previously called LPCN 1021, for approval. Tlando is an oral testosterone proposed as testosterone replacement therapy in adult males with hypogonadism. In June 2016, the FDA turned down the company’s application for the drug, citing inadequacies with its dosing algorithm for the proposed label. After addressing the issues, Lipocine resubmitted the application in August 2017. Based on the committee recommendation, a final decision will be made by May 8, 2018.

2. Aradigm

Based in Hayward, Calif., Aradigm is expecting the Antimicrobial Drugs Advisory Committee of the FDA to review its application for Linhaliq to treat non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa on Jan. 11. The PDUFA date is Jan. 26, 2018.

"FDA informed us, upon acceptance of our NDA, that they were planning an Advisory Committee for Linhaliq," said Igor Gonda, Aradigm’s president and chief executive officer in a statement. "At that time, we began preparing for this meeting together with a team of external key opinion leaders in the fields of chronic lung infections and U.S. drug regulations. We welcome the opportunity to discuss publicly our Linhaliq clinical study results with the Advisory Committee in January. Our ultimate goal is to bring a much-needed therapeutic treatment to NCFBE patients, a population with a high unmet medical need."

3. Synergy Pharma

Located in New York City, Synergy’s supplemental New Drug Application (NDA) for Trulance is awaiting a decision on Jan. 24. The drug has already been approved by the FDA for adults with chronic idiopathic constipation. The supplemental application is for adults with irritable bowel syndrome with constipation. The drug went on the market in March 2017 and in the first nine months of 2017 brought in $7.42 million in sales.

4. Advanced Accelerator Applications

Headquartered in Saint-Genis-Pouilly, France, the company is waiting for an FDA decision on Jan. 26 on Lutathera for gastroenteropancreatic neuroendocrine tumors. The agency rejected the initial application in December 2016, requesting new subgroup data, a safety update, and revisions to the originally submitted data. The drug was approved in Europe in September 2017.

It’s also a busy month for Advanced Accelerator Applications. On Dec. 7, Novartis announcedplans to buy the company for $3.9 billion. The offer expires at midnight Eastern time, on Jan. 19, 2018.

5. Sucampo Pharma

Located in Rockville, Maryland, Sucampo was recently acquired by UK-based Mallinckrodt for $1.2 billion. Sucampo’s supplemental New Drug Application for Amitiza in children six to 17 years of age with pediatric functional constipation will be reviewed by the FDA on Jan. 28. The drug is already approved for adults with chronic idiopathic constipation (CIC) in adults, irritable bowel syndrome with constipation (IB S-C) in adult women, and opioid-induced constipation (OIC) in adults with chronic non-cancer related pain.