GlaxoSmithKline (GSK) has asked the U.S. Food and Drug Administration to withdraw its application for leucovorin calcium, a drug that had been discussed publicly as a possible treatment for autism. The company made the request just months after submitting the application at the request of health officials.
According to a report from the Wall Street Journal, which cited a regulatory filing posted on Thursday, GSK told regulators it was pulling the application because it does not market the medicine. The regulatory filing is the source of the company's stated rationale for the withdrawal.
The FDA had approved leucovorin last month. The agency's approval does not affect the continued availability of generic forms of the medicine, which will remain on the market.
Leucovorin attracted public attention after it was mentioned as a potential autism therapy during a White House press event in September. Robert F. Kennedy Jr. described the drug as an "exciting therapy that may benefit large numbers of children who suffer from autism." His remarks were presented within the context of a broader administration effort to explore causes and more effective treatments for autism symptoms, which the article notes affect one out of every 31 children in the United States.
The filing also unfolded against a backdrop of ongoing debate: Kennedy has previously asserted that vaccines may cause autism, a claim the article states lacks a proven association.
The sequence of events in this case - a company submission at the behest of health officials, FDA approval, and then a request by the applicant to withdraw because it does not market the product - highlights a regulatory and commercial intersection. The immediate practical effect is limited by the continued presence of generic leucovorin preparations on the market.
Additional details about the future commercial custodianship of the branded product or any subsequent regulatory steps were not provided in the filing cited in the report.