Allergan Wins FDA Nod for First Migraine Pill in New Class of Medicines

Allergan Wins FDA Nod for First Migraine Pill in New Class of Medicines

The FDA on Monday approved a pill from Allergan to treat migraine in adults. The treatment, ubrogepant (Ubrelvy), is part of a new class of migraine medicines designed to block calcitonin gene-related peptide (CGRP), a protein thought to play a role in pain transmission.

Ubrogepant is the first CGRP drug in tablet form to get the FDA’s nod. The Allergan (NYSE: AGN) pill is meant to be taken immediately after the onset of migraine by adults. Ubrogepant is indicated regardless of whether migraine is accompanied by aura, strange sensory disturbances that can accompany the condition.

Allergan licensed ubrogepant from Merck (NYSE: MRK) in 2015. In two Phase 3 trials Allergan conducted in about 1,500 patients with a history of migraine, two hours after taking a dose of the drug the percentage of patients that were pain-free and no longer had their “most bothersome symptom” was significantly greater than those taking the placebo.

Although there was initially some concern about potential liver damage from the drug, the drug was approved without a black box warning—the FDA’s strictest notification of health risks associated with a drug—for liver toxicity. That could bode well for New Haven, CT-based Biohaven Pharmaceuticals (NYSE: BHVN), according to a research note from SVB Leerink’s Marc Goodman: The company is hot on Allergan’s heels with rimegepant, its own CGRP pill. Biohaven filed earlier this year for FDA review of the investigational drug and anticipates a decision in the first quarter of 2020.

The most common side effects reported by patients in the ubrogepant trials were nausea, tiredness, and dry mouth. According to the Dublin, Ireland-based company, the drug will be available in the first quarter of 2020. (That’s also when Allergan’s acquisition by AbbVie (NYSE: ABBV), a $63 billion proposal announced in June, is anticipated to close.)

Three injectable drugs that treat the debilitating headaches by blocking CGRP won FDA approval last year. Read about those medicines, from Amgen (NASDAQ: AMGN), Teva Pharmaceutical (NYSE: TEVA), and Eli Lilly (NYSE: LLY), here, here, and here.

Some 37 million people in the US are affected by migraine, according to the American Migraine Foundation. In addition to the headache pain characteristic of the condition, patients may experience nausea, vomiting, and sensitivity to light and sound.

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