Formulary Watch

Regulators are also reviewing Teva’s application for its Prolia biosimilar candidate. The FDA’s decisions are expected mid-year 2025.

PTC Therapeutics' NDA resubmission of Translarna was based on data from Study 041 and the long-term STRIDE registry. No PDUFA action date was provided for regulators.

Gavreto used to treat metastatic RET fusion-positive non-small cell lung cancer and RET fusion-positive thyroid cancer.

Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and gastroesophageal cancers.

Imuldose will be marketed in the United States by Accord BioPharma and is expected to launch in the first half of 2025.

Itovebi is approved to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer in combination with Ibrance and fulvestrant. It will have a cost of $22,867 for a 28-day cycle.

The IQVIA analysis finds that the impact of drug price negotiation on patients’ out-of-pocket spending could also be smaller than expected.

This is the sixth indication for Dupixent and the only biologic approved in the United States to treat COPD.

KarXT — now with the brand name Cobenfy— is expected to be available in October with a list price of about $22,500 annually. The drug represents a new way to treat adults with schizophrenia.

Clinical data suggests an imbalance in vaso-occlusive crises and fatal events that require further assessment, and the company said it will provide updates in the future.

Veklury is indicated to treat adults and children who are hospitalized with COVID-19.

Ocrevus Zunovo can be administrated by providers twice a year with a 10-minute subcutaneous injection. Ocrevus Zunovo will be available in a few weeks and be priced at parity with Ocrevus IV.

Tecentriq Hybreza will be available in a few weeks and be priced at parity with the IV Tecentriq 1200 mg vial.

Zymfentra is a subcutaneous infliximab product used to treat ulcerative colitis and Crohn’s disease. It has a price of $6,181.08 for two shots over four weeks.

The FDA has given mirdametinib a Prescription Drug User Fee Act (PDUFA) action date of Feb. 28, 2025, to treat patients with neurofibromatosis type 1 with tumors that grow along the peripheral nerve.

The FDA has assigned a Prescription Drug User Fee Act of Dec. 20, 2024, for Zynquista (sotagliflozin) to control glycemic levels in adults with type 1 diabetes and chronic kidney disease.

The FDA identified at a third party fill and finish manufacturer. The issues have been resolved, and reinspection is expected in the next few months.

Livdelz is an oral therapy to treat patients with primary biliary cholangitis, a progressive autoimmune disease. It is expected to be available in pharmacies next week.

Zymfentra launched in March 2024 as the first subcutaneous formulation of infliximab for patients with ulcerative colitis and Crohn’s disease. It has a list price of $6,181.08 for two shots over four weeks.

Zunveyl, a prodrug of galantamine that addresses the gastrointestinal side effects, will be available in the first quarter of 2025.

Leqselvi is approved to treat adults with severe alopecia. One-third of patients in clinical trials experienced 80% scalp hair coverage at 24 weeks.

Duvyzat was approved in March 2024 and works to reduce the inflammation and loss of muscle experienced by patients with Duchenne muscular dystrophy.

Epysqli is a monoclonal antibody that is approved to treat two rare conditions that break down red blood cells.

Boehringer Ingelheim’s high- and low-concentration adalimumab-adbm will be available through GoodRx for $550 for two-pack, which represents a 92% discount from the Humira list price.

If approved, tabelecleucel would be the first therapy specifically to treat Epstein-Barr virus related post-transplant lymphoproliferative disease. The FDA’s action date is Jan. 15, 2025.

OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.

Giant cell arteritis is an inflammatory disease that affects the large blood vessels that supply blood to the head and brain.

Genentech had recalled the Susvimo ocular implant two years ago. The FDA has approved changes to the implant and needle.

The prefilled syringe of Vabysmo will become available in the coming months. It treats age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion.

Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe) will be available beginning Feb. 22, 2025 and will be marketed by Sandoz.