FDA Seeks Additional Liver Injury Data on Eli Lilly's Approved Obesity Pill; Appeals Court Remands Maryland Drug Discount Law Case

S. Food and Drug Administration asked Eli Lilly for more data on liver injury linked to its newly approved obesity pill. The request was detailed in a letter posted on the agency website dated April 1.

The letter stated that Eli Lilly must conduct post-marketing trials to assess risks related to cardiovascular events and delayed gastric emptying. Eli Lilly is required to conduct a milk-only lactation study in lactating women who have received a dose of the pill. This study will assess concentrations of the drug in breast milk using a validated assay.

Foundayo won FDA approval earlier this month under the Commissioner’s National Priority voucher program. The weight loss pill branded Foundayo is a once-daily oral medication that targets the GLP-1 hormone. The Commissioner’s National Priority voucher program aims to speed FDA decisions on drugs deemed critical to public health or national security.

U.S. appeals court vacated an order rejecting a request by AbbVie, Novartis, AstraZeneca, and the Pharmaceutical Research & Manufacturers of America to block a Maryland drug discount law. S. Court of Appeals for the Fourth Circuit remanded the decision for review.

The court ruled that a lower court erred when it denied a motion filed by AbbVie, Novartis, AstraZeneca, and the Pharmaceutical Research & Manufacturers of America for a preliminary injunction against the law. B. 1056 is currently in effect and requires manufacturers to distribute discounted drugs to an unlimited number of pharmacies that contract with health providers under the 340B Drug Discount Program.

AbbVie, Novartis, AstraZeneca, and the Pharmaceutical Research & Manufacturers of America argued that the Maryland law improperly forces drug companies to supply contract pharmacies as part of the 340B Drug Discount Program. S. Constitution.