Politics and Policy

Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.

The companies have also initiated a phase 1/2/3 study to evaluate different doses and dosing regimens of the BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.

While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.

RBX2660 — now with the brand name Rebyota — is a potential first-in-class microbiota-based live biotherapeutic that aims to reduce recurrent C. difficile infection.

Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.

This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.

Elucirem requires half the gadolinium dose of existing gadolinium-based contrast agents, addressing practitioners’ concerns about gadolinium exposure during MRIs. It will be available in bottle and pre-filled syringe form.

World Health Organization said there is a lack of evidence of clinical effectiveness of the monoclonal antibodies Xevudy and Regen-Cov against the COVID-19 variants that are currently circulating.

Commercial shipments are already under way of Cosette’s gel formulation of tazarotene to treat patients with acne and facial wrinkles.

Veru is seeking an emergency use authorization for sabizabulin, a first-in-class treatment for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The advisory committee meeting is now Nov. 9, 2022.

There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer. The agency has set a target action date of Jan. 19, 2023.

Skysona, with a wholesale acquisition cost of $3 million, is the first FDA approved therapy to slow progression of neurologic dysfunction in boys with this neurodegenerative disease.

Aponvie is the same formulation as Cinvanti, which is an injectable emulsion for prevention of chemotherapy-induced nausea and vomiting.

The applications are based on progression-free survival data even though the FDA has recommended that the company wait for more mature overall survival data.

Terlivaz is the first approved therapy to treat hepatorenal syndrome, a rare form of kidney disfunction related to advanced liver disease.

Aripiprazole, currently available as a once-monthly injection under the brand name Abilify Maintena, is being reviewed as a two-month therapy. The FDA target date for completion of the review is April 27, 2023.

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, Perrigo’s Opill could be the first-ever over-the-counter birth control pill. The advisory committee meeting is scheduled for Nov. 18, 2022.

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.

In a second committee meeting, FDA advisors supported approval of AMX0035 after the company presented additional analysis of phase 2 data of AMX0035 to treat patients with ALS. The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 29, 2022.

A federal district court ruling today could jeopardize coverage of preventive services recommended by the U.S. Preventive Services Task Force. Some payers may be cautious about pulling back on full coverage of preventive services, but if the ruling stands, experts fear the undoing of a key provision of the Affordable Care Act will result in a patchwork of coverage — and a worsening of healthcare disparities.

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.

If approved, NOV03 would be the first prescription eye drop to address excessive tear evaporation. The FDA has assigned a PDUFA action date of June 28, 2023.