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Reports US

US stock market daily report (February 25, 2014, Tuesday)

February 26, 2014, Wednesday, 06:31 GMT | 01:31 EST | 11:01 IST | 13:31 SGT
Contributed by Millennium Traders


Bristol-Myers Squibb Company (BMY) received approval from the U.S. Food and Drug Administration on February 24 for Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy. During clinical trials, the most common side effects observed in patients treated with Myalept were low blood sugar (hypoglycemia), headache, decreased weight and abdominal pain. The trial showed reductions in HbA1c (a measure of blood sugar control), fasting glucose and triglycerides. Myalept is not approved for use in patients with HIV-related lipodystrophy or in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy.

In an open-label, single-arm study that included 48 patients with congenital or acquired generalized lipodystrophy who also had diabetes mellitus, hypertriglyceridemia, and/or elevated levels of fasting insulin. The safety and effectiveness of Myalept, an analog of leptin made through recombinant DNA technology, were evaluated.

Seven studies or post-marketing requirements, are required by the FDA. The studies include a long-term prospective observational study (product exposure registry) of patients treated with Myalept, a study to assess for the immunogenicity (antibody formation) of Myalept as well as an assessment and analysis of spontaneous reports of potential serious risks related to the use of Myalept.

Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research said, “Myalept is the first approved therapy indicated for treating the complications associated with congenital or acquired generalized lipodystrophy and provides a needed treatment option for patients with this orphan disease.”

Generalized lipodystrophy is a condition associated with a lack of fat tissue. Patients with congenital generalized lipodystrophy are born with little or no fat tissue. Patients with acquired generalized lipodystrophy generally lose fat tissue gradually, over time. Because the hormone leptin is made by fat tissue, patients with generalized lipodystrophy have very low leptin levels. Leptin regulates food intake and other hormones, such as insulin. Severe insulin resistance at a young age is seen in patients with both types of generalized lipodystrophy. Patients are also found suffering from diabetes mellitus that is difficult to control or very high levels of triglycerides in the blood (hypertriglyceridemia) that can lead to inflammation of the pancreas. Anti-drug antibodies with neutralizing activity to leptin and/or Myalept may develop, which could result in severe infections or loss of treatment effectiveness.

Myalept is available only through the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program because of the risks associated with the development of neutralizing antibodies and lymphoma. Prescribers must be certified with the program by enrolling in and completing training, under this REMS program. For each new prescription, pharmacies must be certified with the program and only dispense Myalept after receipt of the Myalept REMS Prescription Authorization Forms.