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LILLY IS A BIG BENEFICIARY OF FDA YEAR-END APPROVALS: AGENCY OKAYS PROZAC AND BETA BLOCKER LEVATOL IN FINAL WEEK; PROZAC WILL BE LAUNCHED IN JANUARY

Executive Summary

Lilly is entering the new year with two new products -- the antidepressant Prozac and the one-a-day beta blocker Levatol -- approved during FDA's year-end clearance of pending NDAs. A third Lilly drug, the H[2] antagonist Axid, reached the approvable stage on Dec. 11. Lilly said Prozac will be on pharmacy shelves by late January. The drug will be marketed by Lilly's Dista division. Prozac was approved by FDA on Dec. 29 following a 4-1/2 year review; the NDA was submitted in September 1983. Although initially indicated for the treatment of depression, Prozac is currently under study for inducing weight loss and for treating alcoholism. Reportedly, Lilly is close to submitting its clinical data to FDA in support of the weight loss claim. A Lilly press release notes that the drug is a "highly specific inhibitor of serotonin uptake," a neurotransmitter linked to depression and other disorders. "The ability of Prozac to selectively block the serotonin uptake process distinguishes it from other medications now used to treat depression," Lilly pointed out. The FDA approved labeling for Prozac notes that the Lilly antidepressant "is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents." The labeling adds that "studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin, but not of norepinephrine, into human platelets." The Clinical Pharmacology section of the labeling also indicates that Prozac is less likely to cause the anticholinergic, sedative, and cardiovascular side effects often associated with tricyclic antidepressants. Prozac is indicated "for the treatment of depression." The drug's efficacy, the labeling reports, "was established in five and six week trials with depressed outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder." According to the labeling, Lilly's clinical submission for Prozac included testing of more than 5,600 patients in the U.S. The label contains a warning for rash and/or urticaria, which occurred in about 4% of patients in clinical trials. The Precautions section cites anxiety and insomnia in 10-15% of patients; anorexia in 9% of patients; activation of hypomania or mania in about 1%; and seizures in .2% of patients. The label notes that "weight loss of greater than 5% of body weight occurred in 13% of Prozac treated patients. . . However, only rarely have Prozac patients been discontinued for weight loss." FDA noted in the approval letter that Lilly has agreed to explore its clinical databases to further assess the relationship of agitation and weight loss. Levatol (penbutolol) was approved New Year's Eve. Licensed from Hoechst-Roussel, which markets the drug in Europe as Betapressin, Levatol is a one-a-day, noncardioselective beta blocker.
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