Six approvals, two rejections highlight FDA Actions during the month of October 2018

Besting September’s approvals, the FDA approved six new drugs during October for the following uses: 
 

• non-nodular moderate to severe acne vulgaris 
• bacterial pneumonia or acute skin and skin structure infection 
• hereditary transthyretin-mediated amyloidosis polyneuropathy in adults
• adenosine deaminase severe combined immune deficiency
• advanced BCRA-positive breast cancer
• acute uncomplicated influenza

This brings the total approvals of novel drugs through the end of October to 47, which surpasses the 46 novel drugs approved in 2017. With two months to go, total approvals may set a new record.
 
Here’s the link to the full details: 
 
During the first week of October 2018

The FDA approved Almirall’s and Paratek Pharmaceuticals’ sarecycline (Seysara) on 10/2/18, ahead of the PDUFA Date, for the treatment of patients aged 9 years and older with inflammatory lesions associated with non-nodular moderate to severe acne vulgaris. No Priority Designations.
 
The FDA approved Paratek Pharmaceutical’s omadacycline (Nuzyra) on 10/2/18, ahead of its PDUFA Date, for the treatment of adults with community-acquired bacterial pneumonia or acute skin and skin structure infection. Omadacycline is a once-daily IV and oral antibiotic. Pricing is expected to be similar to linezolid (Zyvox). The drug had Fast Track and Qualified Infectious Disease Product Priority Designations. 

The FDA has approved Ionis Pharmaceuticals’ inotersen (Tegsedi) on 10/5/18, for the treatment of hereditary transthyretin-mediated amyloidosis polyneuropathy in adults. Inotersen is a once-weekly subcutaneous injection. Inotersen will be available through a REMS program with distribution through Accredo specialty pharmacy, a subsidiary of Express Scripts. The drug has a black box warning for thrombocytopenia and glomerulonephritis. Inotersen will be priced at $450,000. ICER concluded the drug would need to be priced at $96,103 to be cost-effective. The drug has Fast Track and Orphan Drug Priority Designations.
 
The FDA approved elapegademase (Revcovi , Leadiant Biosciences), a new enzyme replacement therapy, on 10/5/18 for the treatment of adenosine deaminase severe combined immune deficiency. 

The FDA rejected ferric maltol during Shield’s first submission, but the company has resubmitted an NDA, which was accepted by the FDA this month.
 
The FDA granted a priority review for Karyopharm Therapeutics’ selinexor and assigned a PDUFA date of April 6, 2019.
 
Week 2
 
The FDA rejectedAcacia Pharma’s amisulpride’s NDA on 10/8/18 due to manufacturing issues.
 
An FDA review of oliceridine was skeptical the drug had less respiratory depression than morphine and the highest dose (0.5mg) appeared to be less efficacious than morphine in analgesic effects, but similar in ADR. Lower doses had few ADR, but less analgesic effects. All strengths of olicerdine provided more analgesic effect than placebo. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of oliceridine.
 
In a review the FDA found sublingual sufentanil tablets to be efficacious for moderate-to-severe acute pain but had concerns over the maximum dosing and the risk of misplaced tablets due to their small size. AcelRx and the FDA have both proposed a REMS program for sublingual sufentanil tablets. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval of sublingual sufentanil tablets.
 
Week 3
 
The FDA approved Medivation’s talazoparib (Talzenna) on October 16, nearly a month ahead of its PDUFA Date, for the treatment of advanced BCRA-positive breast cancer. 

An FDA Advisory Committee voted 10-0 to recommend prucalopride tablets for the treatment of adults with chronic idiopathic constipation. In a review of Shire and Janssen’s prucalopride, the FDA noted that despite the drug being available in Europe since 2009, there have been no controlled trials lasting at least 12-months. In another FDA review, an integrated safety analysis of 2552 patients the most common ADR in prucalopride trials were gastrointestinal disorders including nausea, diarrhea, abdominal pain, and headache with similar cardiovascular events compared to placebo. A final decision on prucalporide is expected in December. The drug does not have a PDUFA Date nor any Priority Designation.
 
Finally, in a slow last week of the month saw the FDA approved Genentech/Shionogi’s baloxavir marboxilon 10/24/18, two months ahead of its PDUFA Date, for the treatment of acute uncomplicated influenza in patients 12 year or older that have been symptomatic for 48 hours or less. There is only one other drug focused on Influenza in the pipeline.

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