Politics and Policy

The new once-daily formulation of Austedo is used to treat adults with tardive dyskinesia and chorea associated with Huntington’s disease.

If approved, RSVpreF would be the first vaccine for administration to pregnant women to help protect against RSV disease in infants. The FDA has set an action date for August 2023.

Filspari will be available for a wholesale acquisition cost of $9,900 for a 30-day supply, and administrated through a REMS program because of the risk of liver abnormalities.

Apellis’ Syfovre will have a list price of $2,190 per vial, and Medicare is expected to be the dominant payer.

The review has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is May 22, 2023.

Lamzeda has been approved to treat patients with alpha-mannosidosis, a rare genetic condition. It will be available in the first half of this year.

The Prescription Drug User Fee Act action date is June 5, 2023. Prevymis is already approved to prevent CMV infection in adults after an allogeneic hematopoietic stem cell transplant.

Avacincaptad pegol has the potential to slow the progression of geographic atrophy in age-related macular degeneration. The PDUFA goal date is Aug. 19, 2023.

Phase 3 data showed that the combination resulted in a 37% reduction in risk of disease progression or death in men with advanced prostate cancer.

The FDA indicated that Soligenix’s application for HyBryte, a novel photodynamic therapy, was incomplete.

If approved, Linzess would be the first and only FDA-approved prescription therapy for functional constipation in children 6 to 17 years of age. The PDUFA date is June 14th, 2023.

Cibinqo is an oral, once-daily JAK1 inhibitor now approved for those 12 years of age and older.

High-priced gene therapies challenge payers to provide access. They are watching the products to be approved the first half of this year.

Conversion from accelerated to regular approval was based on long-term outcomes from a phase 1 trial, which demonstrated an overall response rate of 45.4%.

Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.

If approved, reproxalap would be the first inhibitor of RASP to treat patients with dry eye disease. The FDA PDUFA date is Nov. 23, 2023.

Takhzyro is the first therapy to prevent attacks of hereditary angioedema (HAE) in children ages 2 to under 6.

Zuranolone is a rapid-acting neuroactive steroid that can take effect in 14 days to treat patients with major depressive disorder and postpartum depression. The FDA has assigned a PDUFA action date of Aug. 5, 2023.

The products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis.

Trodelvy has been recommended as a preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network.

Tezspire is a biologic that specifically targets the inflammation associated with asthma.

Daprodustat, now with the brand name of Jesduvroq, is a new oral therapy but it carries a boxed warning about the risk of cardiovascular events.

Elacestrant, now with the brand name Orserdu, is an oral selective estrogen receptor degrader (SERD), which works by blocking the effects of estrogen on hormone receptor-positive breast cancer cells.

Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.

This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.

AstraZeneca is developing a next-generation long-acting antibody for pre-exposure prophylaxis of COVID-19, which it plans to make available in the second half of 2023.

The Peripheral and Central Nervous System Drugs Advisory Committee meeting is scheduled for March 22, 2023, to review Biogen’s tofersen.

Once-daily, oral SGLT2 inhibitor Brenzavvy has been shown to reduce blood sugar and improve glycemic control.

A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.

Moderna plans to submit to the FDA its investigational mRNA vaccine, RNA-1345, for respiratory syncytial virus (RSV) in the first half of 2023.