FDA unveils nine drugs getting streamlined reviews
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Makary. Photo: Nathan Posner/Anadolu via Getty Images
The Food and Drug Administration on Thursday selected nine drugs for expedited reviews intended to speed up the approval process.
Why it matters: The awarding of the new priority review vouchers is a key focus of FDA commissioner Marty Makary, who has called for shaking up how the agency handles drug approvals that can take up to a year.
Driving the news: The nine treatments that could be evaluated in one to two months under the streamlined process include products for Type 1 diabetes, nicotine vaping addiction, blindness and pancreatic cancer.
Between the lines: The moves upend the way FDA customarily does business, because regulators are proactively identifying drug candidates instead of waiting for manufacturers to submit voucher applications.
- "We are not taking a receive-only mode," Makary said on a podcast posted Thursday on his X account. "We are going into the [FDA] divisions asking them tell us what you think is potentially amazing ... and then let's reach out to the companies."
- One of the criteria for receiving the vouchers is affordability — an area that has not normally been in the FDA's purview. The agency customarily focuses on a candidate drug's safety and efficacy.
- The agency is also seeking to use the vouchers to boost U.S. manufacturing, as well as address a "large unmet medical need."
- Some of the products winning the vouchers are already FDA-approved, meaning the priority review is only for approval of a new use.
What they're saying: "We've got to try new things, we have to innovate, we have to be creative, we have to do things differently," Makary said.
- One of the drugs is the combination fertility treatment Pergoveris from EMD Serono, which was part of the Trump administration's announcement Thursday on in-vitro fertilization.
The others are:
- Teplizumab, an already approved antibody from Provention Bio for Type I diabetes.
- Cytisinicline from Achieve Life Sciences for nicotine vaping addiction.
- DB-OTO from Regeneron for deafness.
- Cenegermin-bkbj from Dompé for blindness.
- RMC-6236 from Revolution Medicines for pancreatic cancer.
- Bitopertin from Disc Medicine for porphyria
- Ketamine from Phlow, the anesthetic that's been used as a psychedelic treatment, for U.S. manufacturing.
- Augmentin XR from USAntibiotics for domestic manufacturing of a common antibiotic
Makary said more voucher awardees would be announced in a "couple weeks."
