Top officials at the U.S. FDA have internally urged its reviewers to speed up the evaluation of Eli Lilly’s (LLY) marketing application for its weight loss pill orforglipron after the Indiana-based drugmaker pushed for a faster review timeline, Reuters reported on Friday.
According to internal documents, the FDA Commissioner’s Office has sought to shorten the time reviewers spend assessing if marketing applications for drugs such as orforglipron, selected for a new Priority Voucher program, have enough information from 60 days to one week.
However, internal pushback has prompted the Commissioner’s Office to indicate that it may cut those review timelines to 2 or 3 weeks, depending on a marketing application’s complexity.
If implemented, an FDA decision on orforglipron’s filing could be expected by as early as March 28, well ahead of a May 20 action date set by the reviewers, according to the documents.
With Novo Nordisk’s (NVO) oral version of its weight-loss therapy Wegovy currently under FDA review with a decision expected this month, a potential approval of LLY’s pill could spark a new battle between the companies in the market for oral obesity drugs.
In June, the FDA unveiled the FDA Commissioner’s National Priority Review voucher program to shorten the review timelines for certain drugs from the standard 10–12-month period to 1–2 months from the filing of a marketing application.
So far, 15 drugs, including orforglipron and a higher-dose version of Novo Nordisk’s (NVO) weight-loss therapy Wegovy, have been selected for the program, which the FDA said was launched to benefit companies serving U.S. national priorities.