Formulary Watch

The FDA has granted priority review of velmanase alfa, an enzyme replacement, to treat patients with alpha-mannosidosis, a rare genetic disease. The FDA has assigned an action date in the first half of 2023.

If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare, genetic neurological disorder mostly in girls. The FDA action date is March 12, 2023.

Developed by Bristol Myers Squibb, Sotyktu is the first approved TYK2 inhibitor. It is expected to be available later this month.

Rolvedon, which previously had the brand name Rolontis, is the first novel long-acting GCSF product approved in more than 20 years. Spectrum Pharmaceuticals expects it to be available in the fourth quarter.

The FDA is expected to make a decision on Pfizer’s ritlecitinib in the second quarter of 2023.

Daxxify enters the injectable botulinum toxin market as a twice-a year treatment for frown lines.

Dr. Reddy’s received a first-to-market 180 days of exclusivity for the 2.5 mg and 20 mg strengths of its generic lenalidomide capsules.

If approved, SER-109 to treat recurrent C. diff infections could be the first-ever FDA approved oral microbiome therapeutic.

Fresenius Kabi expects to launch Stimufend as a prefilled syringe early in 2023.

The FDA would not issue an emergency use authorization for Eiger BioPharmaceuticals’ peginterferon lambda to treat patients with mild-to-moderate COVID-19.

A phase 3 trial showed that Imfinzi in combination with chemotherapy reduced the risk of death by 20% compared with chemotherapy alone.

Konvomep, an oral liquid of omeprazole and sodium bicarbonate, will be available in the first quarter of 2023

With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.

Spevigo is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling approved to treat for adults with generalized pustular psoriasis flares.

This application is for a new formulation of carbidopa/levodopa extended-release capsules to treat patients with Parkinson’s disease.

Xenpozyme, the first disease-specific treatment for acid sphingomyelinase deficiency (ASMD), is expected to be available in the United States in the coming weeks at a wholesale acquisition cost of $7,142 per vial.

Ryaltris is a fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in a nasal spray.

The approval of the updated bivalent boosters is based on data from clinical studies of the omicron variant BA.1, and animal data on the omicron BA.4 and BA.5 variant.

This recall of propofol because of particulates seen in vials follows a previous one in July 2022.

The direct-to-consumer pharmacy also added 13 new products, and now carries almost 1,000 medications.

The target action date for the agency’s decision for efanesoctocog alfa, a factor VIII therapy, is Feb. 28, 2023.

Hyftor was approved in April 2022 to treat patients with the rare disease facial angiofibroma associated with tuberous sclerosis complex.

Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.

Imbruvica is the first approved treatment option for children under 12 with chronic graft versus host disease and the first BTKi therapy approved for pediatric patients.

Pending authorization, Moderna will be ready to ship the updated bivalent booster in September 2022.

Omnipod 5 is now available through retail pharmacies, as well as specialty and mail-order pharmacies.

The updated COVID-19 vaccine booster specifically addresses the omicron BA.4/BA.5 variants. If authorized, it will be available to ship immediately.

Novavax’s vaccine is the first protein-based COVID-19 vaccine authorized in the United States.

Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.

Recent approvals include a first generic for the infertility drug Cetrotide, as well as generics of Revatio, Velcade and Esbriet.