The voucher allows for an expedited 6-month review of the drug’s pending New Drug Application with the FDA.
Biohaven has finalized the purchase of a Priority Review Voucher to use alongside its New Drug Application for rimegepant Zydis® ODT, its orally available, small molecule calcitonin gene-related peptide receptor antagonist for the acute treatment of migraine in adults.1
The voucher purchase comes on the heels of additional Phase 3 data further supporting rimegepant’s favorable safety and tolerability profile in patients with episodic migraine.2
“This transaction highlights the important benefits to patients of the priority review voucher program — the program motivates more treatments to be developed for rare pediatric diseases and also speeds approval of potential blockbuster therapies,” said Biohaven CEO Vlad Coric, MD, in a statement.1 “We are excited about the potential of bringing rimegepant Zydis ODT to patients as quickly as possible.”
Biohaven plans to submit the New Drug Application for rimegepant in the second quarter of 2019.
Efficacy and safety profiles of the orally dissolving formulation have been demonstrated in 3 completed Phase 3 studies and 1 ongoing Phase 2b study. In the most recent trial (NCT03461757), treatment with rimegepant 75 mg improved pain freedom (21.2% vs 10.9%; P <.0001) and freedom from the most bothersome symptom, including photophobia, phonophobia, or nausea (35.1% vs 26.8%; P =.0009), greater than placebo at 2 hours following a single dose. Notably, pain relief was apparent in the treatment group as early as 15 minutes post-dose, with the difference between rimegepant and placebo reaching statistical significance at 1 hour. Clinical benefit for freedom from pain, pain relief, and freedom from the most bothersome symptom was noted through 48 hours in the treatment arm. Adverse events, including nausea and urinary tract infection, had a low incidence and were mild in nature, with 1.5% and 1.2% of the treatment group reporting symptoms, respectively.
1. Biohaven secures Priority Review Voucher (prv) to expedite regulatory review of Rimegepant Zydis ODT new drug application [news release]. New Haven, Conn: Biohaven Pharmaceuticals; March 18, 2019. https://www.biohavenpharma.com/investors/news-events/press-releases/03-18-2019
2. Biohaven delivers positive phase 3 results with Rimegepant Zydis® orally dissolving tablet (ODT): rapid and lasting benefit for the acute treatment of migraine [news release]. New Haven, Conn: Biohaven Pharmaceuticals; December 3, 2018. https://www.prnewswire.com/news-releases/biohaven-delivers-positive-phase-3-results-with-rimegepant-zydis-orally-dissolving-tablet-odt-rapid-and-lasting-benefit-for-the-acute-treatment-of-migraine-300758762.html