Eli Lilly’s Oral Weight Loss Drug: Fast-Tracked by FDA

CC Exclusive Analysis

In an effort to make largely effective weight loss drugs easier to take, avoiding regular and unpleasant injections, several pharmaceutical manufacturers are making progress on oral options. According to an article from Reuters today, Indianapolis-based drug-maker Eli Lilly’s new experimental oral weight loss drug, orforglipron, may be fast-tracked via a new one- to two-month FDA review process named the Commissioners National Priority Voucher, according to Wall Street analysts. Traditional reviews take on average 10 months.

To be eligible for this expedited review, the FDA has said it needs to support at least one of the below:

• Address a U.S. public health crisis;
• Deliver innovation;
• Address a large unmet medical need;
• Onshore drug development and manufacturing; or
• Increase affordability.

Additionally, Lilly’s Danish competitor, Novo Nordisk’s GLP-1 oral drug is currently being reviewed by the FDA with a decision expected in Q4.