Drugs

Tolmar Pharma Drug Approved for Early Puberty

FDA has approved a Tolmar Pharmaceuticals NDA for Fensolvi (leuprolide acetate) for injectable suspension for treating pediatric patients two years of age and older with central precocious puberty (CPP). The rare disease is defined as the onset of puberty before age eight in girls and before age nine in boys, according to the company. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological and emotional issues, it says.

Tolmar says that leuprolide acetate is the most widely used treatment for CPP. Fensolvi uses a propietary polymeric gel technology that forms an in-situ solid after injection and releases leuprolide acetate in a sustained and controlled manner over time. “This polymeric gel technology enables a small volume of injection of only 0.375mL, subcutaneous administration, and a six-month dosing cycle,” the company says.

Approval was based on data from a single-arm Phase 3 study in 64 children with CPP. The study met its primary endpoint, according to Tolmar, with 87% achieving a serum luteinizing hormone target concentration at six months post injection. The study also demonstrated that Fensolvi suppressed sex hormones to pre-pubertal levels, and stopped or reversed the progression of clinical signs of puberty, the company says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome