Three Companies with FDA Decisions in the Next Week

Published: May 15, 2018 By

FDA3

There are a few upcoming approval dates for several companies this week. Let’s take a look at the companies and their products awaiting approval.

  1. Evolus. Evolus’s prabolutinumtoxinA for severe glabellar lines—better known as “frown lines”—has a PDUFA date of May 15. On April 5, 2018, the company, located in Irvine, California, presented results of its Phase III head-to-head comparative trial of EVB-003 at the 2018 Aesthetic & Anti-Aging Medicine World Congress (AMWC) held in Monte-Carlo, Monaco. It expanded upon data presented in February at the American Academy of Dermatology (AAD) meeting. Evolus’ product was compared to Allergan’s Botox (onabotulinuymtoxinA), where it showed “non-inferiority.” The product is also under review by the European Medicines Agency (EMA).
  2. Amgen. Amgen’s Aimovig for migraine has a PDUFA date of Thursday, May 17. The FDA accepted Amgen’s Biologics License Application (BLA) for Aimovig (erenumab) for review on July 20, 2017. The drug is for the prevention of migraine in patients that experience four or more migraine headaches per month. If it’s approved, it is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, designed specifically for the prevention of migraine.

The application was based on pivotal trials of more than 2,600 patients having four or more days of migraine per month. Phase II and III trials of the drug compared to placebo showed a reduction in the number of migraine-affected days, disability and acute medication use for patients. The safety profile was similar to placebo.

Aimovig decreased migraine days by about 50 percent in about a third of patients receiving it. In the Phase IIIb LIBERTY trial, 246 patients who had two to four previous treatments that didn’t work were randomized to receive monthly subcutaneous injections of either 140 mg of Aimovig or placebo for 12 weeks. Patients receiving Aimovig also met all secondary endpoints, including reduction in monthly migraine days, decreased migraine-specific drug use per month, a reduction of 75 percent or more in monthly migraine days, and a 100 percent reduction in monthly migraine days.

If approved, Amgen and its partner Novartis will co-commercialize the drug in the U.S. Amgen holds exclusive commercialization rights to it in Japan, and Novartis has exclusive rights to commercialize it in the rest of the world.

GlobalData, an analytics company, projects that CGRP antibodies such as Aimovig, will create combined sales of $4 billion by 2026.

Although Amgen and Novartis are ahead in this market, several other companies are focusing on it as well. These include Eli Lilly’s galcanezumab, Teva Pharmaceuticals' fremanezumab and Alder BioPharmaceuticals eptinezumab.

  1. Dova Pharmaceuticals. And coming up on Monday, May 21, the FDA is expected to make a decision on Dova Pharmaceuticals’ New Drug Application (NDA) for avatrombopag for thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. The submission was built on two identically-designed Phase III clinical trials, ADAPT 1 and 2. Avatrombopag met all primary and secondary endpoints with high statistical significance.

The application was accepted under a Priority Review status, which moved the review time from 10 months to a goal of six months. The drug is a second generation orally administered TPO-RA.

In a November 2017 statement, Alex Sapir, president and chief executive officer of Dova, said, “We are extremely pleased that FDA has accepted our NDA submission with Priority Review. We believe that avatrombopag represents a novel treatment option with robust efficacy as well as an improved safety profile when compared to platelet transfusions, today’s current standard of care. We look forward to working closely with FDA through the review process.”

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