Politics and Policy

Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment in those with early Alzheimer’s disease.

Regulators need additional time to review information on bone mineral density. The FDA has provided a new PDUFA date of Aug. 6, 2022.

The move to limit Janssen’s vaccine comes after an analysis finds there is a risk of thrombocytopenia syndrome (TTS), a rare syndrome of blood clots and low levels of blood platelets.

The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.

The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.

The Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022; the PDUFA date is August 4, 2022.

Orphalan plans to launch Cuvrior in early 2023. It was approved to treat Wilson’s disease, which results in excess copper in the body.

The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.

The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.

Qelbree is the first new nonstimulant to be approved in 20 years.

The complete response letter identified the need for additional chemistry, manufacturing, and controls data related the drug product and manufacturing process.

The FDA’s Vaccines and Related Biological Products Advisory Committee has scheduled a meeting on June 7, 2022.

The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.

Moderna is also studying booster doses of the COVID-19 vaccine for all pediatric cohorts.

Now called Camzyos, the therapy is first-in-class and treats the underlying cause of the disease. It is expected to be available next week.

Vivjoa is an oral therapy and the first for chronic yeast infections. It is expected to be available in the second quarter of 2022.

Ultomiris is the first approval for a long-acting C5 complement inhibitor for the treatment of generalized myasthenia gravis, a rare, chronic, autoimmune neuromuscular disease.

Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.

The FDA has set a Prescription Drug User Fee Act date for tremelimumab during the fourth quarter of 2022.

The FDA is seeking input from committee members about the phosphate lowering effect seen in trials for tenapanor, which now has the brand name of Xphozah.

The FDA is expected to make decisions on several products later this week, including mavacamten, Qelbree, meloxicam-rizatriptan, surufatinib and toripalimab.

The World Health Organization now recommends Paxlovid and Veklury for non-severe COVID-19 at high risk of hospitalization but still advises against use in mild disease with low risk of hospitalization.

The EMA’s Committee for Medicinal Products for Human Use indicated that the data provided is not sufficient for marketing authorization.

The new PDUFA date for is Sept. 8, 2022, for daxibotulinumtoxinA, Revance’s therapy to treat frown lines.

The FDA has approved miglustat for Gaucher disease. Breckenridge launches pencillamine for Wilson’s disease and lacosamide for seizure disorder.