FDA Updates for Week of March 14, 2022

FDA approves first generic of Symbicort for asthma and COPD.

The FDA has approved the first generic of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Called Breyna, the drug-device combination was developed by Mylan Pharmaceuticals, a subsidiary of Viatris.

FDA approves first therapy for rare seizure disorder.

The FDA has approved Ztalmy (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy, in patients two years of age and older. Ztalmy, developed by Marinus Pharmaceuticals, is the first FDA approved treatment specifically in CDD. It is a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor.

Ztalmy is expected to be available through a designated specialty pharmacy in July 2022, according to executives with Marinus.

FDA approves Rinvoq for ulcerative colitis.

The FDA has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of adults with moderately to severely ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This approval is the first indication for Rinvoq in gastroenterology. It was approved in two dose strengths (15 mg and 30 mg).

This approval is the first indication for Rinvoq in gastroenterology. Rinvoq is a JAK inhibitor and is also approved to treat moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and moderate-to-severe atopic dermatitis.

FDA approves Lynparza for early breast cancer.

The FDA has approved Merck’s Lynparza (olaparib) for the treatment of adult patients with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer after surgery or prior chemotherapy.

The approval was based on results from the phase 3 OlympiA trial, including data for the trial’s primary endpoint of invasive disease-free survival. Lynparza reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% versus placebo. Updated results from the OlympiA trial showed Lynparza reduced the risk of death by 32% versus placebo. The updated overall survival data will be presented at an upcoming European Society for Medical Oncology Virtual Plenary on March 16, 2022.

FDA approves new delivery system for Alzheimer’s disease.

The FDA has approved Corium’s Adlarity (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia related to Alzheimer’s disease. Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of donepezil through the skin, resulting in a low likelihood of adverse gastrointestinal side effects associated with oral donepezil. Adlarity will be available in early fall 2022.

Donepezil is the most prescribed medication in a class of Alzheimer's drugs and is the active ingredient in the oral medication Aricept. Adlarity delivers a consistent dose of donepezil through a patient’s skin over seven days.

Adlarity is the first approved prescription drug product using Corium’s proprietary Corplex transdermal technology. The platform allows for transdermal delivery of small molecule drugs thought to be incapable of being delivered through the skin. It is the same technology used in Corium’s partner’s Procter & Gamble's Crest Whitestrips product.

FDA extends review of Opzelura for skin condition.

The FDA has extended the review period for the supplemental new drug application (sNDA) for Incyte’s Opzelura (ruxolitinib cream) for the treatment of vitiligo. The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18, 2022. Previously, the date was April 18, 2022.

This move was made to allow time to review additional data from the ongoing phase 3 studies submitted by Incyte in response to the FDA’s information request. The submission of the additional information has been determined by the FDA to constitute a major amendment to the sNDA, resulting in an extension of the PDUFA goal date.

Vitiligo is a disease that causes the loss of skin color. Vitiligo occurs when cells that produce melanin die or stop functioning. Vitiligo affects people of all skin types, but it may be more noticeable in people with darker skin. The exact cause is unknown, but it is believed to be an autoimmune condition.

The FDA issues complete response letter for Fasenra.

The FDA has issued a complete response letter (CRL) regarding the supplemental biologics license application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps.

The sBLA submitted to the FDA by included data from the OSTRO phase 3 trial, which met both co-primary endpoints with a safety profile consistent with the known profile of the medicine, according to the company. The CRL requested additional clinical data and the company is working closely with the FDA regarding next steps. AstraZeneca is conducting a second phase 3 trial, ORCHID, in this indication.

Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce depletion of blood and tissue eosinophils. It is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the United States, the European Union, Japan, and other countries.