Regulatory Updates

Tibsovo is currently approved in the United States as a monotherapy to treat adults with IDH1-mutant relapsed or refractory acute myeloid leukemia.

The FDA has granted priority review for cefepime-taniborbactam to treat patients with complicated urinary tract infections and set an action date of Feb. 22, 2024.

Elrexfio is a bispecific antibody to treat relapsed or refractory multiple myeloma. It will be available within the next few weeks and have a monthly list price of $41,500.

Daxxify is a long-acting botulinum toxin that will launch in 2024. It previously received FDA approval to treat frown lines.

The combination of niraparib and abiraterone in a single tablet — now with the name Akeega — will be available in mid-September and have a list price of $18,750 for a 30-day supply.

Talvey is a first-in-class bispecific antibody to treat adult patients with relapsed or refractory multiple myeloma. It will available in a few weeks and have a price of $45,000 per month.

Avasopasem was under review to treat radiotherapy-induced severe oral mucositis in patients with head and neck cancer. The FDA has indicted that an additional trial would be needed to show safety and effectiveness of avasopasem.

The FDA has assigned a March 8, 2024, action date for GA Depot, a once-monthly injection to treat patients with relapsing forms of multiple sclerosis.

Izervay, which is expected to be available within the two to four weeks, will have a list price of $2,100 per vial.

Zurzuvae is a rapid-acting neuroactive steroid that is expected to be available in the fourth quarter of 2023.

Trial results showed that the combination of Lonsurf and bevacizumab provided improvements in overall survival.

Jemperli is the first immuno-oncology treatment approved in the frontline setting for patients with advanced or recurrent endometrial cancer.

Rezzayo is a novel once-weekly antifungal to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain. It will have a wholesale acquisition cost of $1,950 per vial.

The FDA is requiring Citius Pharmaceuticals to do enhanced product testing for Lymphir (formerly I/Ontak) to treat patients with cutaneous T-cell lymphoma.

Harm Reduction Therapeutics will supply at least 200,000 free doses of RiVive to communities that need it most.

Xdemvy is the first treatment that directly targets the mites involved in the Demodex blepharitis. It is expected to be available by the end of August 2023 and will have a list price of $1,850 per prescription.

If approved, Ofev would be the first approved treatment for children and adolescents with fibrosing interstitial lung disease. A decision is expected in the fourth quarter of this year.

Ycanth, a topical treatment for molluscum contagiosum, will be available in September. Pricing information has not yet been released.

Emergent BioSolutions has been providing the Cyfendus vaccine to the U.S. Department of Health and Human Services since 2019, under a pre-emergency use authorization status.

Vanflyta is the first FLT3 inhibitor approved to treat patients with newly diagnosed acute myeloid leukemia across three phases of treatment. It has a list price of $199,290 annually.

Beyfortus will be available ahead of the upcoming 2023-2024 RSV season. A price has not yet been set.

Donanemab slowed cognitive decline by about 35% for patients at the earliest stages of Alzheimer’s disease.

Opill will be available in stores and online in the first quarter of 2024.

Takeda indicated that it could not address issues related to aspects of data collection within the current BLA review cycle.

The label for Leqvio has also been updated to remove four adverse events based on recent safety data.

Medicare will cover Alzheimer’s drugs with full approval, including Leqembi — if the physician and patient participate in a real-world registry trial to gather additional data.

Zolbetuximab is a first-in-class therapy for advanced gastric and gastroesophageal cancers. The target action date is Jan. 12, 2024.

The FDA is asking for more pharmacokinetic data on carbidopa, one of the drugs within IPX203. The therapy is an extended-release, oral formulation of carbidopa/levodopa.

BioMarin is offering an outcomes-based warranty that will reimburse payers up to 100% of the cost if a patient does not respond to Roctavian.

Longer-acting growth hormone reduces frequency of injections. It will be available in August.