Product Approvals and Launches

Full approval by the FDA follows tentative approval for the complex drug delivery advice for asthma and chronic obstructive pulmonary disease (COPD) granted by the FDA last week amid a patent dispute.

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 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.

The oral polymerization inhibitor, a first-in-class therapy for sickle cell disease, was first approved by the FDA for adults and pediatric patients 12 years of age and older in 2019.

The FDA approved FoundationOneCDx as the first companion diagnostic for current and future BRAF inhibitor therapeutics used to treat melanoma, including both monotherapies and combination therapies.

An FDA advisory panel voted in favor of emergency authorization for Merck's COVID-19 pill; South African drug maker Aspen Pharmacare announced that it was finalizing the first agreement to control production of the Johnson & Johnson COVID-19 vaccine in Africa; the International AIDS Society launched its latest strategy to find a cure for HIV.

The first-of-its-kind port delivery system with ranibizumab serves as the first wet age-related macular degeneration (AMD) treatment in 15 years to provide an alternative to frequent eye injections.

Sold under the name Dupixent, dupilumab is a biologic that inhibits interleukin (IL)-4 and IL-13, which are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and eosinophilic esophagitis.

The product, called Rethymic, is composed of human allogeneic thymus tissue that is processed and cultured and then implanted into children born without a thymus to help reconstitute immunity.

Maralixibat is the first treatment approved for cholestatic pruritus in patients with Alagille syndrome who are 1 year or older.

Ruxolitinib cream, to be sold under the name Opzelura, is the first topical Janus kinase inhibitor cream for the treatment of atopic dermatitis.