Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Allergan plc?(NYSE: AGN) today announced that the?U.S. Food and Drug Administration?(FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults. The NDA filing is based on the successful completion of four clinical trials ? two pivotal studies, ACHIEVE I and ACHIEVE II, which demonstrated the efficacy, safety and tolerability of ubrogepant, as well as two additional safety studies. A 10-month review period has been assigned with the Prescription Drug User Fee Act (PDUFA) in the fourth quarter of 2019.
"Following the acceptance and expected review of this NDA, we anticipate ubrogepant to be the first approved oral CGRP receptor antagonist for the acute treatment of migraine, and may be used in conjunction with other available migraine treatments," said?David Nicholson,?Chief Research?and Development Officer,?Allergan. "As a leader in Chronic Migraine research for more than 20 years,?Allergan?looks to provide options for patients who need new acute and preventative treatments for migraine. In addition to ubrogepant, we are continuing to advance the Phase 3 clinical program for atogepant, the company's second orally-administered investigational CGRP receptor antagonist specifically for migraine prevention."
In the four clinical studies (ACHIEVE I, ACHIEVE II, UBR-MD-04 and 3110-105-002) supporting the NDA, ubrogepant demonstrated efficacy, safety and tolerability in the acute treatment of migraine among a broad patient population, including those who had an insufficient response to a triptan or those patients in whom triptans were contraindicated, as well as in patients who had moderate to severe CV risk profile. Following are topline results from the key clinical studies:
Phase 3 Clinical Trials (ACHIEVE I & ACHIEVE II)
- The two pivotal Phase 3 clinical trials demonstrated the efficacy, safety and tolerability of orally administered ubrogepant (ACHIEVE I at 50 mg and 100 mg; and ACHIEVE II at 25 mg and 50 mg) compared to placebo to treat a single migraine attack in adults.
- The 50 mg and 100 mg doses met the studies' co-primary endpoints, demonstrating a statistically significant greater percentage of ubrogepant patients achieving pain freedom and absence of most bothersome symptom at two hours after the initial dose as compared to placebo patients; there was continued separation from placebo up to 48 hours.
- The 50 mg and 100 mg doses also met key secondary endpoints, demonstrating a statistically significant greater percentage of ubrogepant patients achieving pain relief at two hours after the initial dose compared to placebo patients.
- Study UBR-MD-04: Phase 3, multicenter, randomized, 52-week open-label extension trial in which adults with migraine were randomized 1:1:1 to usual care, ubrogepant 50 mg, or ubrogepant 100 mg to assess long-term safety and tolerability.
- Intermittent use of ubrogepant 50 mg or 100 mg for the acute treatment of migraine attacks over one year was well-tolerated. The three most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.
- Study 3110-105-002: Phase 1, multicenter, double-blind, parallel-group trial evaluated the safety and tolerability of ubrogepant 100 mg, focusing on hepatic safety in healthy participants administered high frequency intermittent ?dosing (2 days of ubrogepant 100 mg followed by 2 days of placebo for 8 consecutive weeks).
- Ubrogepant 100 mg was well-tolerated following frequent dosing and was not associated with persistent increases in ALT/AST compared to placebo, supporting liver safety.