FDA Confirms Paragraph IV Patent Litigation for Ubrogepant Tablets
AbbVie`s Ubrelvy significantly cuts headache pain if taken during prodrome
NORTH CHICAGO, Ill., Aug. 5, 2020 /PRNewswire/ -- AbbVie today announced Serena Williams as the spokesperson for UBRELVY® to raise awareness of an effective acute treatment option for people living with migraine. Whether at work, taking care of kids, or preparing for a Grand Slam Championship tennis match like Serena, UBRELVY can provide relief of migraine attacks. Unlike older migraine medicines that primarily work by constricting blood vessels after a migraine attack has already begun, UBRELVY is the first pill of its kind for the acute treatment of migraine to directly block a protein called CGRP (calcitonin gene-related peptide), which is believed to play a critical role in migraine attacks. Available by prescription since January 2020, UBRELVY is approved for the acute treatment of migraine with or without aura in adults. It is not indicated for the preventive treatment of migraine.s
Eli Lilly's Emgality has been gaining steam in the new CGRP class of migraine prevention drugs, and now it has a new colleague: Reyvow, the first med in a new class of acute treatments.
In the run-up to an FDA decision on its migraine pill, Biohaven is brandishing a second weapon from its CGRP arsenal — an intranasal formulation — that it says has hit the main goals of a Phase II/III trial.
Allergan has revealed positive Phase 3 data on its oral calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant, illustrating the therapy’s strength compared to placebo in the acute treatment of migraine.
After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H.I.V. with a daily pill.
Aiming to break into a three-way battle among large drugmakers in the brand-new CGRP migraine class, tiny Biohaven Pharmaceutical has released detailed data for its own candidate, which one group of analysts figures could reach blockbuster status.
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.
Allergan $AGN rolled out its second wave of positive Phase III data for its oral migraine drug ubrogepant, which nailed its endpoints in the higher dose but failed to elicit much effect in the lower amount.