Product Approvals and Launches

The approvals were announced by Bristol Myers Squibb (BMS), maker of the 2 immunotherapy treatments approved for 1 combination: nivolumab (Opdivo), the first approved PD-1 immune checkpoint inhibitor, and ipilimumab (Yervoy), which activates the immune system by targeting CTLA-4.

Eosinophilic esophagitis is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, proliferate in the esophagus, causing difficulties with eating and swallowing.

The treatment was found to improve glycemic control and is indicated to be used in conjunction with diet and exercise.

This approval of trastuzumab deruxtecan (Enhertu) follows the March release of data from the DESTINY-Breast03 trial on the anti-HER2 monoclonal antibody, also a HER2-directed antibody-drug conjugate, which indicated superior outcomes vs trastuzumab emtansine.

The drug, oteseconazole, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis in females who are infertile or postmenopausal.

A new drug has been approved for obstructive hypertrophic cardiomyopathy (HCM); Oklahoma enacts a strict abortion ban; whistleblower claims alarms had been raised about Abbott baby formula contamination.

Alymsys from Amneal Pharmaceuticals and mAbxience is the third biosimilar referencing Avastin approved in the United States and the second of 3 biosimilar approvals Amneal expects in 2022.

The expanded use of axi-cel, sold as Yescarta, while not unexpected, nonetheless represents uncharted territory in cancer care.

The FDA approved a drug to treat a rare form of childhood epilepsy; uninsured Americans will no longer have access to free COVID-19 tests; a conservation group is suing the Environmental Protection Agency (EPA) over failure to protect rivers from pollution.

The FDA based its approval on OlympiA trial data, which show the PARP inhibitor has the ability to reduce risks of invasive breast cancer recurrence, second cancers, and death, and to improve overall survival.

Steven Yeh, MD, professor of ophthalmology at the Truhlsen Eye Institute at the University of Nebraska Medical Center, explains the delivery mechanism and benefits of Xipere for macular edema.

Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, becomes the third filgrastim biosimilar to be approved by the FDA.

Steven Feldman, MD, PhD, professor of dermatology at Wake Forest School of Medicine, discusses what makes clascoterone (Winlevi) different from past acne treatments.

FDA approval is based on CARTITUDE-1, a phase 1b/2 trial in which investigators reported that cilta-cel produced an objective response rate (ORR) of 98% and a stringent complete response rate of 78%.

Jardiance (empagliflozin) received approval from the FDA for a new indication to treat heart failure in a broader range of patients, including those with preserved ejection fraction.

The treatment was approved in October 2021 and is the first FDA-approved therapy to treat macular edema associated with uveitis via injection to the suprachoroidal space, which provides a more targeted delivery mechanism.

Foundation Medicine’s circulating tumor DNA (ctDNA) detection and monitoring assay, FoundationOne Tracker, was granted a Breakthrough Device Designation from the FDA, streamlining the approval and review processes to give patients and providers earlier access to the device.

The drug will be marketed by Sanofi under the name Enjaymo; it is the first treatment approved for cold agglutinin disease.

The JAK1 inhibitor abrocitinib (Cibinqo) was recently approved by the FDA for the treatment of adults with refractory, moderate to severe atopic dermatitis.

Americans who are boosted are 95 times less likely than unvaccinated people to die of COVID-19, the FDA approved the first generic drug for Restasis to treat dry eye syndrome, and CMS is putting a greater focus on health equity for Medicare Advantage and Part D plans.

This represents the approval of the first bispecific antibody to treat wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

The first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years launched in the United States in November 2021 after being approved in August 2020.

Daridorexant belongs to a class of drugs known as a dual orexin receptor antagonists.

Cullinan Oncology’s CLN-081 today received a Breakthrough Therapy Designation from the FDA for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC).

Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.

The FDA this week approved cabotegravir (Apretude), the first and only long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1.

Secukinumab is approved for use among patients with enthesitis-related arthritis (ERA) aged 4 years and up, and those with psoriatic arthritis (PsA) who are at least 2 years old.

Up to 500 million at-home COVID-19 test kits will be sent to US households for free, by request; Biogen cut the price of its Alzheimer disease drug Aduhelm nearly in half; the FDA approved the world’s first injectable medication to reduce the risk of sexually transmitted HIV.