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Teva’s migraine injection approved in Europe

Third anti-CGRP treatment to hit the market

Ajovy

The European Medicines Agency has approved Teva’s migraine prevention drug Ajovy, adding a third competitor to a fast-expanding market.

Ajovy is another anti-calcitonin gene-related peptide (CGRP) inhibitor, adding to the two already approved on both sides of the Atlantic: Novartis and Amgen's Aimovig, the first-to-market for migraine prevention, gaining European approval in August last year, followed by Lilly's Emgality in November.

Evaluate Pharma's forecasts make it clear which product is tipped to lead the market: it expects Aimovig to be way out in front by 2024, with estimated sales of $2.05bn that year. It predicts Emgality could hit $1.2bn by this time, with Ajovy forecast to reach $962m.

Ajovy is given as a dose of two injections at 120mg each, then at a monthly dose supplied in an auto-injector - similar to Aimovig..

“Migraine can have a significant impact on the day-to-day life of patients with some experiencing 15 headache days per month,” said Richard Daniell, executive vice president, European Commercial at Teva.

Richard Daniell

Teva's Richard Daniell

“It is our hope that Ajovy will provide patients and European healthcare professionals with a preventive treatment which offers patients more migraine free days as well as greater flexibility in managing this unpredictable disease.”

The drug was approved based on the results of two phase 3 trials, which saw the Ajovy-treated patients achieve a significantly greater reduction in migraine days compared to placebo.

More specifically, on average, those with chronic migraine taking the monthly dosing treatment had 4.6 fewer headache days per month, compared to 2.5 days with placebo.

Meanwhile, Alter Biopharmaceuticals is also developing an anti-CGRP treatment known as eptinezumab, but won’t have the flexibility of at-home administration like the other drugs in the class.

The FDA also recently accepted an NDA from Botox developer Allergan, which filed its oral CGRP ubrogepant for the acute treatment of migraine in adults.

The success of Ajovy is absolutely essential for Teva, which is enduring a very difficult period. CEO Kåre Schultz has cut thousands of jobs at the Israel-headquartered firm as it struggles to pay off debts and deal with shrinking revenues. Its income is expected to slip 8% to 10% in 2019, thanks to the decline of its biggest seller, MS drug Copaxone. To reverse the trend, Teva needs Ajovy (fremanezumab) and Austedo  for tardive dyskinesia and chorea associated with Huntington’s disease to achieve rapid take up, with both treatments now launched.

4th April 2019

From: Regulatory

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