FDA advisers to vote on potential approval of 3 more anti-psychotic drugs for youngsters

FDA panel to vote on psychiatric drugs for kids

WASHINGTON — Advisers to the Food and Drug Administration are scheduled to vote Wednesday on whether three powerful psychiatric drugs should be approved for children, despite side effects that can increase the risk of diabetes.

A positive decision from FDA would expand the use of a class of drugs that accounted for more than $14.6 billion in sales last year, according to health care analysis firm IMS Health.

The FDA will ask its panel of psychiatric experts whether drugs from AstraZeneca PLC, Eli Lilly & Co. and Pfizer Inc. should be approved to treat schizophrenia and bipolar disorder in patients ages 10 to 17. The drugs already are approved to treat those conditions in adults.

On Tuesday, the companies each presented data from studies that lasted between three and six weeks and compared their drugs to placebo.

FDA officials told panelists the drugs appear to be effective for younger patients, though concerns remain about their side effects, including weight gain, high blood sugar and sleepiness.

Patient and consumer groups said the companies should have conducted more in-depth studies to look at the long-term effects of the medications.

“We need to hold these drugs to higher standards,” Stephanie Portes-Antoine of the Patient and Consumer Coalition said at Tuesday’s meeting. “They should be proven safe and effective for long-term use since the treatment will be long-term.”

The group’s membership includes the Consumers Union, National Women’s Health Network and a half-dozen other non-profits.

The FDA on Wednesday will ask the 10 members of its psychiatric drug advisory committee to discuss the benefits and risks of each medication and then vote on whether it should be approved for younger patients.

The FDA is not required to follow the advice of its panels, though it usually does.

AstraZeneca and Lilly are seeking permission to market their drugs — Seroquel and Zyprexa, respectively — for adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pfizer is seeking approval to market its pill Geodon for bipolar patients ages 10 to 17.

With only two anti-psychotic drugs currently approved for younger patients, a positive decision for the three drugs would significantly increase competition in the market for anti-psychotics — the top-selling class of prescription medications in the U.S. last year, according to IMS Health.

Currently, only Bristol-Myers Squibb’s Abilify and Johnson & Johnson’s Risperdal are approved for use in younger patients.

Abilify was the second best-selling anti-psychotic drug in the U.S. last year with sales of $3 billion. Risperdal was fourth with $1.6 billion in sales, according to IMS Health.

Those drugs and the three under FDA consideration are all known as atypical anti-psychotics, a class of treatments introduced in the 1990s that were designed to be safer and more effective than older drugs.

But recent studies have concluded the newer drugs are no more effective than those first developed in the 1950s. And while atypical anti-psychotics do not have the older drugs’ risks of tremors and muscle spasms, they have their own side effects — such as weight gain and high blood sugar — which can increase the risk of diabetes.

Because the newer drugs are still under patent they generally sell for between $300 and $500 per month, compared with the $100 price on original anti-psychotics.

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