FDA Updates

Rejoyn from Otsuka Pharmaceutical and Click Therapeutics is a 6-week program that helps enhance cognitive control of emotions through brief therapy lessons and training exercises.

The approval of vadadustat (Vafseo) from Akebia Therapeutics was based on data from the phase 3 INNO2VATE program.

Following quality concerns voiced by the FDA regarding plastic syringes made in China, medical technology company BD has announced it will increase its production of plastic syringes in the US.

Tenofovir alafenamide was originally approved by the FDA in 2016 to treat adults with chronic HBV infection with compensated liver disease and in 2022 to treat pediatric patients aged 12 years and older.

The approval represents the first non-statin treatment indicated to lower low-density lipoprotein for primary prevention patients.

Mirvetuximab soravtansine-gynx (Elahere) was first granted FDA accelerated approval in November 2022.

Aprocitentan (TRYVIO) from pharmaceutical company Idorsia demonstrated statistically significant and clinically meaningful reductions in blood pressure in combination with other antihypertensive therapies.

The approval was based on data from the phase 1/2 TRANSCEND CLL 004 study, in which the CAR T cell therapy demonstrated statistically significant complete response rates.

The approval, awarded to Madrigal Pharmaceuticals, was based on phase 3 data demonstrating that resmetirom achieved broad treatment effects in patients with MASH with liver fibrosis.

Study results demonstrated the efficacy of semaglutide (Wegovy) in reducing cardiovascular risks in adults with overweight or obesity without diabetes.

A clinical trial showed that nivolumab plus chemotherapy significantly improved overall survival and progression-free survival compared with a chemotherapy combination alone.

This is the fifth oncology indication for zanubrutinib in the United States.

Dexcom's Stelo will be available in summer 2024.

The agency approved denosumab-bddz under two brand names: Wyost and Jubbonti.

June 7, 2024 is the target PDUFA date for the additional indication of GSK's respiratory syncytial virus vaccine Arexvy.

Eosinophilic esophagitis is a chronic, progressive disease thought to be responsible for damaging the esophagus, and it can severely impact a child’s ability to eat.

The NDA was submitted for investigational muscarinic antipsychotic, KarXT (xanomeline-trospium), which functions as a dual M1/M4 muscarinic acetylcholine receptor agonist within the central nervous system.

The perfluorohexyloctane ophthalmic solution from Bausch + Lomb was approved by the FDA in May and will have a whole acquisition cost of $771 for a one-month supply.

Lodoco (colchicine) approval was based on a clinical trial with 5,522 patients with chronic coronary disease, which was published in Circulation in February 2022.

The medication is broadly approved for heart failure with preserved or reduced ejection fraction.

The approval of Rinvoq (upadacitinib) was based on the results of three clinical trials: two induction therapy studies and one maintenance study.

Otsuka America Pharmaceutical and Lundbeck’s Alify Asimtufii (aripiprazole) also was approved for maintenance monotherapy treatment of bipolar I disorder in adults.

The drug treats amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS).

Ruxolitinib (Opzelura) cream is the first and only FDA-approved treatment for patients with vitiligo.

From medication to legislation, multiple developments have advanced the pharmacy profession this year.

Merck and Ridgeback Biotherapeutics have announced their submission of an EUA application to the FDA for an oral antiviral medication for the treatment of COVID-19.

Five medications are currently approved by the FDA for chronic weight management.

Sol-Gel Technologies has created a single-application acne treatment cream, combining 2 commonly used ingredients: tretinoin and benzoyl peroxide.

The FDA has approved the AstraZeneca once-weekly injectable therapy for use in children aged 10 to 17 years.