Posted by SLS on February 6, 2001, at 10:03:19
Monday February 5 5:46 PM ET
FDA Approves Pfizer Schizophrenia Drug
WASHINGTON (Reuters) - U.S. regulators on Monday approved Pfizer Inc.'s (NYSE:PFE - news) schizophrenia treatment Zeldox, setting the stage for a high-stakes marketing battle with two treatments that already boast blockbuster sales.
A Food and Drug Administration spokeswoman said regulators cleared the drug, known generically as ziprasidone, for sale in the United States. Schizophrenia is a psychosis believed to affect about one percent of the world's population, in which people have delusions and hallucinations, often hearing voices.
The FDA had declined to approve Zeldox in 1998 over concern that some patients taking it in clinical trials had ``QT prolongation,'' a heartbeat irregularity linked to an increased risk of rare but potentially fatal heart-rhythm disturbances.
But a panel of outside experts concluded last July that the drug's effectiveness outweighed any risks.
The FDA has required that the Zeldox package insert label warn patients and doctors about QT prolongation and risk of sudden death.
But the agency did not require that a severe ``black-box'' warning be placed on the label, a safeguard the agency reserves for drugs deemed to have especially worrisome side effects.
Analysts said Zeldox had advantages that could make it a
strong competitor to two top-selling schizophrenia drugs, Eli Lilly and Co.'s (NYSE:LLY - news) Zyprexa and Johnson & Johnson's (NYSE:JNJ - news) Risperdal.
``The real long-term question is whether Zeldox demonstrates equal efficacy to Zyprexa. That really is a question mark in the minds of leading physicians,'' said Barbara Ryan, a Deutsche Banc Alex. Brown drug analyst.
Studies have shown that Zeldox relieved schizophrenia symptoms with little or no weight gain. Other anti-psychotic drugs can cause weight gain of up to 20 pounds a year, a side effect that leads some patients to stop taking the medications regularly.
``Patients on Zeldox don't have the weight gains'' or have higher risk of developing type II diabetes, side effects that are both seen with Zyprexa, said Banc of America Securities analyst Len Yaffe.
``But Zyprexa has the advantage of being dosed just once a day, versus twice a day for Zeldox, and is not associated with the potential to cause irregular heartbeat,'' Yaffe added.
Yaffe said Zyprexa had global sales of almost $2.4 billion in 2000 and that they are expected to rise to $2.9 billion this year. Risperdal had global sales of $1.6 billion in 2000, including $1.1 billion in the United States.
The FDA approval was announced late on Monday, shortly before the close of stock trading. On the New York Stock Exchange, Pfizer shares closed up 85 cents at $45.75, while Lilly fell $2 to $79.90 and Johnson & Johnson fell $1.17 to $93.93.