Ryzumvi Mydriasis Reversal Drops, Exxua for MDD, Likmez Metronidazole Liquid Formulation, DNA Test for Hereditary Cancers, Tofidence Actemra Biosimilar, Pompe Disease Combination Therapy, Subcutaneous Entyvio, NurOwn in ALS

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Here are the highlights:

Ryzumvi (Phentolamine Ophthalmic Solution) for Dilated Pupil Reversal

The FDA has approved Ryzumvi for treating pharmacologically-induced mydriasis (dilated pupils). Ryzumvi, formerly known as Nyxol, will be available in the US in 2024 and is currently the only commercially available treatment for reversing dilated eyes.

Exxua (Gepirone Hydrochloride) for MDD

Exxua, an antidepressant, has received FDA approval for the treatment of major depressive disorder in adults. Exxua has faced regulatory challenges in the past. It works through selective agonism of 5HT1a receptors without causing common antidepressant side effects like sexual issues or weight gain.

Likmez, Liquid Formulation of Metronidazole

The FDA has approved Likmez, the only liquid oral suspension of metronidazole in the US. The liquid formulation provides an alternative for patients who struggle with the tablet version due to taste or swallowing difficulties.

DNA Test for Hereditary Cancers

The FDA granted marketing authorization for Invitae Common Hereditary Cancers Panel, a diagnostic test identifying genetic risks for certain cancers. This is the first FDA-approved test of its kind, with over 99.0% accuracy in detecting variants in 47 cancer-associated genes.

Tofidence (Actemra [toclizumab] Biosimilar)

Tofidence, a biosimilar referencing Actemra, has been approved by the FDA for certain rheumatologic indications. A biosimilar, it closely resembles the FDA-approved biologic Actemra in safety, purity, and efficacy.

Pombiliti + Opfolda for Pompe Disease

The FDA approved Pombiliti + Opfolda, a two-component therapy for adults with Pompe disease. The therapy shows significant improvements in patient mobility and is designed to address enzyme deficiency while maintaining it’s efficacy in Pompe disease.

Subcutaneous Entyvio (Vedolizumab) for Moderate-to-Severe Ulcerative Colitis

The FDA has approved a subcutaneous form of Entyvio for maintenance therapy in adults with ulcerative colitis. Previously approved as an intravenous formulation, this subcutaneous version achieved significant clinical remission in trials for use as maintenance therapy.

Experimental Stromal Cell Platform in Mild-To-Moderate ALS

The FDA Advisory committee voted against the effectiveness of BrainStorm Cell Therapeutics’ NurOwn stromal cell therapy for mild to moderate ALS. BrainStorm Cell Therapeutics plans to initiate a phase 4 study in 2024.

Intro and outro music

Garden Of Love by Pk jazz Collective

The New FDA Approvals podcast is a weekly podcast that aims to help clinicians, medical writers, and pharmaceutical industry executives stay up to date on the latest FDA approvals. Join Dr. Emma Hitt Nichols each Monday morning for an update on the previous week’s FDA activities.

• No. of episodes: 60
• Latest episode: 2024-07-29
• Education Health & Fitness Medicine

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