By Sneha S K
Oct 16 (Reuters) - The U.S. Food and Drug Administration
on Thursday announced the names of nine products, under a new
fast-track review process, which could potentially get approval
within one to two months of filing a complete application.
The regulator said it has selected Merck KGaA's
fertility drug Pergoveris, Sanofi's Type 1 diabetes
drug teplizumab, Regeneron's DB-OTO for deafness and
ketamine for domestic manufacturing of a general anesthetic.
These will have shorter review times compared to the typical
timeline of about 10-12 months.
The FDA's list also includes Revolution Medicines' ( RVMD )
RMC-6236 for pancreatic cancer, Disc Medicine's ( IRON )
bitopertin for porphyria, Achieve Life Sciences' cytisinicline
for nicotine vaping addiction as well as Dompe's cenegermin-bkbj
for blindness and augmentin XR for domestic manufacturing of a
common antibiotic.
Shares of Revolution rose 7.4%, while Disc Medicine ( IRON ) rose 19%
in extended trading.
The FDA in June launched the new Commissioner's National
Priority Voucher pilot program under which it could issue
vouchers to companies aligned with major national priorities,
such as meeting a large unmet medical need, reducing downstream
health care utilization, or addressing a public health crisis.
The new program will convene experts from the regulator's
offices for a team-based review, instead of using the standard
review system, where a drug application is sent to numerous FDA
offices.
Each drug review division within the FDA has been charged
with nominating a product while companies can also apply and
have their request reviewed, the FDA said on Thursday.
The agency expects to announce another group of products
under the new program in the coming months.
Eli Lilly's ( LLY ) experimental weight-loss pill,
orforglipron, could be fast-tracked under the new voucher
process, analysts had speculated last month. The FDA's list on
Thursday did not include orforglipron.
Lilly called the program a promising initiative adding,
"while it's too early to discuss how this submission pathway
might relate to any of our specific programs, we look forward to
learning more from the Administration," the company said in an
emailed response.