FDA News

Recent FDA actions you may have missed

Endocrine Today has compiled a list of recent FDA news stories relating to endocrine practice. Drugs under consideration included those for thyroid eye disease, diabetes, hypertriglyceridemia, Prader-Willi syndrome and nonalcoholic steatohepatitis.

FDA prioritizes thyroid eye disease medication review

Priority review has been granted for the investigational medication teprotumumab for treatment of thyroid eye disease, according to a press release from Horizon Therapeutics.

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FDA draft guidance aims to facilitate biosimilar insulin development

New draft guidance is designed to help facilitate the development of insulin products for people with type 1 and type 2 diabetes, part of a broader effort to increase market competition, lower costs for patients and payors and increase access and product choice.

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FDA panel unanimously supports CV event risk reduction indication for icosapent ethyl

The Endocrinologic and Metabolic Diseases Advisory Committee of the FDA voted 16-0 in favor of the safety and efficacy of icosapent ethyl, based on available data, to support its approval for an indication to reduce risk for CV events.

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FDA fast tracks intranasal oxytocin analogue for Prader-Willi syndrome

Fast track designation was granted for intranasal carbetocin, an oxytocin analogue, for the treatment of Prader-Willi syndrome, according to a press release from Levo Therapeutics.

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FDA advisory committee rejects recommending approval of lower-dose empagliflozin for type 1 diabetes

The Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 against recommending approval of a supplemental new drug application for the SGLT2 inhibitor empagliflozin 2.5 mg as an oral medication adjunct to insulin therapy for adults with type 1 diabetes, with committee members citing uncertainty regarding the adjudication of diabetic ketoacidosis and a lack of adequate data to support evidence for safety and efficacy.

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FDA grants fast track designation to FXR agonist for NASH

The FDA granted fast track designation to Terns Pharmaceuticals for TERN-101, an investigational farnesoid X receptor being evaluated for nonalcoholic steatohepatitis, according to a press release.

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Endocrine Today has compiled a list of recent FDA news stories relating to endocrine practice. Drugs under consideration included those for thyroid eye disease, diabetes, hypertriglyceridemia, Prader-Willi syndrome and nonalcoholic steatohepatitis.

FDA prioritizes thyroid eye disease medication review

Priority review has been granted for the investigational medication teprotumumab for treatment of thyroid eye disease, according to a press release from Horizon Therapeutics.

READ

FDA draft guidance aims to facilitate biosimilar insulin development

New draft guidance is designed to help facilitate the development of insulin products for people with type 1 and type 2 diabetes, part of a broader effort to increase market competition, lower costs for patients and payors and increase access and product choice.

READ

FDA panel unanimously supports CV event risk reduction indication for icosapent ethyl

The Endocrinologic and Metabolic Diseases Advisory Committee of the FDA voted 16-0 in favor of the safety and efficacy of icosapent ethyl, based on available data, to support its approval for an indication to reduce risk for CV events.

READ

FDA fast tracks intranasal oxytocin analogue for Prader-Willi syndrome

Fast track designation was granted for intranasal carbetocin, an oxytocin analogue, for the treatment of Prader-Willi syndrome, according to a press release from Levo Therapeutics.

READ

FDA advisory committee rejects recommending approval of lower-dose empagliflozin for type 1 diabetes

The Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 against recommending approval of a supplemental new drug application for the SGLT2 inhibitor empagliflozin 2.5 mg as an oral medication adjunct to insulin therapy for adults with type 1 diabetes, with committee members citing uncertainty regarding the adjudication of diabetic ketoacidosis and a lack of adequate data to support evidence for safety and efficacy.

READ

FDA grants fast track designation to FXR agonist for NASH

The FDA granted fast track designation to Terns Pharmaceuticals for TERN-101, an investigational farnesoid X receptor being evaluated for nonalcoholic steatohepatitis, according to a press release.

READ