Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) has risen after a US regulatory staff mentioned about a plan to tackle the risks of a company’s drug.
Aegerion has gained 9.40% to $17.46 in Monday’s session. This was after the declaration of the staff report from Food and Drug Administration. An advisory panel is supposed to meet on 17th October on the medicine lomitapide. It is the lead product candidate of Aegerion based in Massachusetts. FDA is supposed to make a final decision on this by the end of December.
The pill is supposed to be taken everyday and it aims at treating a hereditary condition known as familial hypercholesterolemia about abnormalities in liver cells responsible for clearing LDL (low density lipoprotein) particles from blood. The ailment can result in heart attack or death at a early age, as per the National Institutes of Health. The consultative panel will consider a similar drug from Isis Pharmaceuticals and Sanofi on 18th October.
The risk plan would support suitable use of lomitapide, allowing it to be permitted for use in the projected patient population with life threatening illness and limited therapeutic choices.
The FDA may need risk evaluation and mitigation strategies that go beyond drug labeling to make sure the benefits of a medication compensate the risks.
An analyst at Think Equity Partners in San Francisco said in a telephone interview that it does not believe that larger studies will be required given the REMs. The FDA has recommended the REMs agenda to better evaluate the drug safety.
Out of 19 patients in a clinical test, 17% has experienced the presence of an amplified enzyme in their blood that shows signs of liver damage. The FDA suggests Aegerion’ risk management plan include educating prescribers about liver risks and the need for checking patients with blood tests.