Approval of New J&J Diabetes Drug Reflects Regulators' Ongoing Safety Concerns

Posted 01 April 2013 By Alexander Gaffney, RF News Editor

US regulatory officials have announced the approval of Johnson & Johnson's new type 2 diabetes product, Invokana (canaglifilozin)-the first sodium-glucose co-transporter 2 (SGLT2) inhibitor approved by the agency.

"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," said Mary Parks, director of the Division of Metabolism and Endocrinology Products (DMEP)at FDA's Center for Drug Evaluation and Research (CDER). "We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health."

In a statement, J&J said the drug is markedly different from other existing therapies in that it is thought to block the absorption of glucose in the kidneys, causing it to be excreted through a patient's urine instead.

"What has historically been viewed as a sign of diabetes - glucose in the urine - may also reflect the efficacy of a new and unique approach to treatment," Richard Aguilar, medical director at the Diabetes Care Foundation, said in a statement on behalf of J&J.

The approval comes just days after FDA and the European Medicines Agency (EMA) raised significant concerns about the risks of pancreatitis and cancer associated with incretin mimetic medicines in the GLP1 and the DPP4 classes of type 2 diabetes medicines. Those drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

While Invokana was not observed to have similar risks associated with it during its clinical testing-10,285 patients tested in nine separate trials-FDA is requiring at least two postmarketing trials of the drug's pancreatitis and cancer risks. Three other trials will assess the drug for the risk of cardiovascular problems, hypersensitivity, photosensitivity, liver abnormalities, adverse pregnancy outcomes, bone safety and two pediatric studies under the Pediatric Research Equity Act (PREA).

Common side effects associated with the drug's usage included vaginal yeast infections, urinary tract infections, and low blood pressure (hypotension).

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Categories: US, FDA, CDER

Tags: Diabetes, J&J

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