Politics and Policy

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.

In two small studies, patients were able to be free from insulin injections for a year or more.

At issue is an ongoing review of inspection results from a third-party filling company. No issues were cited in the FDA’s complete response letter about clinical efficacy or safety.

It will be commercially available in the third quarter of 2023 and have a list price of $6,050 per vial.

Pfizer’s biologics license application (BLA) for the gene therapy fidanacogene elaparvovec has been assigned a PDUFA date in the second quarter of 2024.

Blincyto is immuno-oncology therapy that targets CD19 surface antigens on B cells to treat patients with acute lymphoblastic leukemia. Its current wholesale acquisition cost price is $4,900.15 per vial.

Now with the name Litfulo, ritlecitinib is the first oral treatment for adolescents with alopecia. It has an annual list price of $49,000.

Elevidys is a one-time therapy that delivers to muscle a gene that codes for a shortened, functional form of dystrophin, which is mutated in Duchenne muscular dystrophy.

The company plans to discontinue further research of obeticholic acid to treat nonalcoholic steatohepatitis (NASH) after the FDA asked for long-term outcomes data.

Regulators indicated there was a lack of evidence of effectiveness and lack of clinical trials done to support the application.

Vyvgart Hytrulo’s under-the-skin administration means it can be given in 30 to 90 seconds, compared with one hour for the intravenous product. It will be priced at parity to Vyvgart, which has a net price of $225,000 annually.

Jardiance and Synjardy are the first SGLT2 inhibitors approved for children with type 2 diabetes.