FDA Approves Teva's Migraine Drug Ajovy -- Update

Date : 09/14/2018 @ 8:35PM
Source : Dow Jones News
Stock : Teva Pharmaceutical Industries Limited American Depositary Shares (TEVA)
Quote : 24.36  -0.47 (-1.89%) @ 4:43PM

FDA Approves Teva's Migraine Drug Ajovy -- Update

Teva Pharmaceutical Industries Limited American Depositary Shares (NYSE:TEVA)
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   By Maria Armental 
 

The U.S. Food and Drug Administration has approved for sale Teva Pharmaceutical Industries Ltd.'s (TEVA, TEVA.TV) migraine drug Ajovy, the latest in a new class of drugs that target a brain chemical known as CGRP.

Researchers have found that CGRP, which stands for calcitonin gene-related peptide, is involved in the brain's pain-signaling during migraines.

Ajovy should be available in about two weeks, Teva said, and its wholesale-acquisition cost--an industry term for the price drug companies charge wholesalers--will be about $575 for a 225 mg monthly dose and $1,725 for a 675 mg quarterly dose.

The most common adverse reactions in clinical trials were injection-site reactions, the company said.

Amgen Inc. and Novartis AG's Aimovig, the first of the new type of migraine drugs to hit the U.S. market, was approved in May with a list price of $6,900 a year.

Teva, the world's biggest seller of generic drugs, had been counting on the approval of Ajovy, or fremanezumab, to boost sales.

"The way we recover is Ajovy," Chief Executive Kåre Schultz said last month.

The Israeli drugmaker reported a 14% revenue decline for the first half of the year, which the company has attributed in part to continued pricing pressure in its U.S. generics business and generic competition to multiple-sclerosis drug Copaxone.

Shares, which have outperformed the market with a 21% gain this year, rose 6% to $24.25 in after-hours trading.

 

Write to Maria Armental at maria.armental@wsj.com

 

(END) Dow Jones Newswires

September 14, 2018 20:20 ET (00:20 GMT)

Copyright (c) 2018 Dow Jones & Company, Inc.

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