AstraZeneca’s MYALEPT receives FDA approval

AstraZeneca confirmed yesterday (February 25th) the US Food and Drug Administration (FDA) has approved its drug MYALEPT.

"MYALEPT is the first approved therapy, as an adjunct to diet, to help treat the complications of leptin deficiency affecting the lives of children and adults with generalised lipodystrophy," said Briggs Morrison, executive vice-president of global medicines development and chief medical officer of AstraZeneca.

The medicine is a recombinant analogue of human leptin that can reduce the accumulation of fat in organs and help patients control blood sugar more effectively. It is the first and only treatment approved by the FDA for these  affected patients.

AstraZeneca is currently working to finalise the transition of the Biologics License Application for MYALEPT from Bristol-Myers Squibb. The drug and licence were part of the acquisition of the diabetes alliance assets, which was completed by AstraZeneca ?at the start of this month.