Formulary Watch

If approved, mosunetuzumab could be the first T-cell engaging bispecific antibody for the treatment of any type of non-Hodgkin’s lymphoma. The FDA has assigned a PDUFA date of Dec. 29, 2022.

Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Jan. 6, 2023.

The Peripheral and Central Nervous System Drugs Advisory Committee will meet for a second time in September 2022 to discuss new analysis of the data for AMX0035 for the treatment of patients with amyotrophic lateral sclerosis.

The United States has acquired adult and pediatric doses of the COVID-19 vaccine for delivery in early fall in a contract worth $3.2 billion, as well as an additional 150,000 doses of bebtelovimab for about $275 million.

Qsymia is only available through a Risk Evaluation and Mitigation Strategy (REMS) program because of the increased risk for birth defects.

The removal of prior authorizations for buprenorphine for use in opioid use disorder was associated with a statistically significant increase in the number of prescriptions filled among Medicaid populations in Illinois but not in California, which had already been seeing an increase in use of such therapies.

Effective July 1, 2022, CVS Caremark has removed 16 drugs and added 14 to its Standard Control Formulary.

The new PDUFA date is Nov. 17, 2022. If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes.

NRx Pharmaceuticals had been seeking emergency use for Zyesami for COVID-19 respiratory failure. The company will now focus on clinical research for its therapy for patients with bipolar disorder.

The submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated people at high risk for progression to severe illness from COVID-19.

Zelnorm is used to treat adult women less than 65 years of age with irritable bowel syndrome with constipation.

Palovarotene is being reviewed as a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of Dec. 29, 2022.

The FDA is accepting comments on the proposed rule through Oct. 26, 2022.

Sanofi has lowered the out-of-pocket cost for those without insurance of its insulins to $35 for a 30-day supply through the company’s savings program.

Regeneron is seeking an additional dosing regimen with a longer-term interval between doses. The PDUFA date is Feb. 28, 2023.

Spero Therapeutics was seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection. The FDA has requested an additional clinical trial.

If approved, lenacapavir would be the first HIV-1 treatment administered twice-yearly.

The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.

Diacomit was approved in 2018 for seizures associated with Dravet syndrome, a rare pediatric disorder.

Labels now warn that buprenorphine products that dissolve in the mouth can cause dental problems. Buprenorphine is used to treat opioid use disorder and pain.

Breyanzi is now available as a second-line treatment for this aggressive blood cancer.

Generics of Viibryd, Tranxane and Timoptic have recently been approved and launched.

Byetta is used to control blood sugar in patients with diabetes. A new warning includes the risk of gallstones and gallbladder inflammation.

Benefits leaders surveyed in PSG’s Trends in Drug Benefit Design Report say the importance of the member experience has increased since the start of the pandemic.

Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.

The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.

Increased demand for certain medications used to treat hospitalized patients with COVID-19 had a significant impact on medication supply last year.

The company will take no profit, which is part of the company’s bankruptcy filing and settlement with states.