FDA Advisory Panel: Obesity and Hypoparathyroidism Drugs Receive Nod of Approval

Obesity: Saxeda

An advisory panel to the FDA has recommended that the drug liraglutide (Saxenda, Novo Nordisk) can be used to treat chronically obese patients with at least 1 weight-related health issue, such as hypertension. The panel voted 14-to-1 in favor of the recommendation.

The same drug is already approved to treat diabetes under the name Victoza.

In a study, 50% of obese patients who were given the 3 mg daily injection lost 5% of their body weight and 22% reported a 10% loss.

An FDA report noted a high rate of breast malignancies among women who took the drug, but did not conclude the drug’s role in cancer promotion or progression. The drug is also associated with higher resting heart rates and gallbladder-related problems.
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Hypoparathyroidism: Natpara

An advisory panel to the FDA voted 8-to-5 to recommend approval for Natpara (NPS Pharmaceuticals, Inc), a bioengineered, long-term hormone replacement therapy to treat hypoparathyroidism.

Hypoparathyroidism is a rare condition when the parathyroid glad does not secrete enough parathyroid hormone (PTH). PTH works with vitamin D to regulate body calcium.

To make its recommendation, the committee reviewed data from 1 pharmacology study and 4 efficacy and safety trials, including REPLACE—a randomized, double-blind, placebo controlled study and the largest clinical trial in hypoparathyroidism to date.

References:

FDA. FDA briefing document: liraglutide. 2014 Sep 11. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM413317.pdf. Accessed September 15, 2014.

FDA. FDA briefing document: Endocrinologic and Metabolic Drugs Advisory Committee Meeting. 2014 Sep 12. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM413617.pdf. Accessed September 15, 2014.