FDA clears next-generation schizophrenia pill

	Tweet

U.S. regulators on Wednesday approved a new once-a-day treatment for schizophrenia derived from the active ingredient in Johnson & Johnson’s blockbuster schizophrenia treatment Risperdal.

The pill, called Invega, is the first new schizophrenia treatment to win U.S. Food and Drug Administration approval since 2003, according to J&J.

Schizophrenia is a chronic, disabling mental disorder that affects more than 2 million Americans. Symptoms include hallucinations, delusions, disordered thinking, movement disorders, social withdrawal and cognitive deficits, such difficulty with perception, memory or abstract thinking. 

The new treatment is designed to deliver paliperidone—the active ingredient in Risperdal—through a technology that allows the drug to remain in the body over a longer period of time.

“Schizophrenia can be a devastating illness requiring lifelong medication and professional counseling,” said Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research.

“Today’s approval adds to the treatment options for patients with this condition,” he said in a statement announcing the approval.

Wall Street analysts see the approval as key to J&J’s drug portfolio. JP Morgan analyst Michael Weinstein has called Invega “the most important drug in J&J’s pipeline.”

In a note to clients last month, Weinstein said a year-end approval would give J&J 18 months to market the drug before the start of generic competition for its older drug Risperdal.

Risperdal and the injectable long-acting version Risperdal Consta had combined sales of more than $1 billion in the most recent quarter.

J&J will market Invega in the United States by the company’s Janssen LP unit.

Invega is part of a class of drugs known as atypical antipsychotics. Introduced in the 1990s, the drugs now account for some $10 billion in U.S. sales. 

RELATED STORIES:
US FDA says generic Wellbutrin OK despite reports   FDA approves Pfizer drug to help smokers   Memantine cost-effective for severe Alzheimer’s   Back to Basics: Aspirin After Knee Surgery   New Guidelines for Prescribing Opioid Pain Drugs Published   Study: Few buy drugs online   Illegal Drug Trade Yields 10-15bn Dollars Yearly in Russia   Europe orders full safety probe of Cox-2 drugs   Hypersensitivity Reactions to the Quadrivalent HPV Vaccine Are Rare   Genentech Colon Cancer Drug Works with 2nd Chemo   Pfizer stops arthritis drug Bextra sales   Non-profit drug research needs $1 bln injection

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]