Serostim Reviewed By FDA Joint Panel

Just after the Marketletter went to press, Serono Laboratories' Serostim (mammalian cell-derived recombinant human growth hormone) was due to be evaluated by a joint advisory committee to the US Food and Drug Administration. The panel was scheduled to review safety and efficacy data for Serostim for the treatment of AIDS wasting on March 1; details on the outcome of the appraisal will be included in the next issue of the Marketletter.

Serono filed a New Drug Application with the FDA for approval of Serostim in the treatment of AIDS wasting in September 1995. In the meantime, more than 800 Americans with AIDS wasting have received the drug, through a treatment Investigational New Drug access program authorized by the FDA.

Serono notes that over 750 of these people have been fully or partially reimbursed through private insurance or Medicaid, determined on a case-by-case basis. The average third-party reimbursement is 85%. Ten state Medicaid systems, including Medi-Cal, the second-largest Medicaid program in the country, and more than 120 private insurance companies, have authorized reimbursement for Serostim. The company has provided the drug free-of-charge to over 35% of the total number of people enrolled in the tIND program.