Zacks Investment Research | Apr 13, 2017 05:46AM ET
Shares of Neurocrine Biosciences, Inc. (NASDAQ:NBIX) soared 25% on Tuesday after announcing the FDA approval ofIngrezza (valbenazine) capsules a day before for the treatment of adults with tardive dyskinesia (TD). Ingrezza is the first and the only drug approved by the FDA for the treatment of adults with TD.
Neurocrine’s shares outperformed the Zacks classified Medical Drugs industry year to date. The stock rallied 34% compared with the industry’s gain of 0.5%.
The company said that Ingrezza, a-selective VMAT2 inhibitor, has been studied in more than 1,000 individuals and more than 20 studies. The studies showed that INGREZZA significantly improved TD symptoms compared to placebo, through six weeks. It also helped in reducing involuntary movements observed through 48 weeks of treatment. These results, combined with convenient once-daily dosing, represent a huge opportunity for patients suffering from TD.
Now with limited options available for the treatment of TD, the approval of Ingrezza is a good news for Neurocrine. Neurocrine has created the INBRACE patient support program, which will immediately start accepting treatment initiation forms from health care professionals prescribing INGREZZA. The INBRACE program will work closely with patients and provide them with customized services.
Moving ahead, Ingrezza will be available through a select pharmacy network and promotion to healthcare professionals will begin on May 1, 2017.
Manwhile, Ingrezza’s approval could pose a threat to pharmaceutical giant, Teva Pharmaceutical Industries Limited’s (NYSE:TEVA) drug Austedo (deutetrabenazine) which is in line to get approval for the treatment of TD. Teva’s new drug application (NDA) for deutetrabenazine was granted priority review by the FDA in Feb 2017. Furthermore, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2017.
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