The US Food and Drug Administration (FDA) on Friday announced that it’s withdrawing approval of AbbVie’s new drug applications (NDAs) for the cholesterol drugs Advicor (niacin extended-release [ER] and lovastatin) and Simcor (niacin ER and simvastatin) as new research shows the benefits of the drugs no longer outweigh the risks.
“Based on the collective evidence from several large cardiovascular outcome trials, the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events,” FDA said. “Consistent with this conclusion, FDA has determined that the benefits of Advicor and Simcor no longer outweigh the risks, and approval should be withdrawn.”
In an SEC filing from February, the company noted that net revenues for AbbVie's consolidated lipid franchise, which included three drugs in addition to Advicor and Simcor, declined 45% in 2015 and 70% in 2014. Most of that reduction was due to the introduction of generic versions in November 2012 for TriCor, July 2013 for Trilipix, and September 2013 for Niaspan.
The company also noted in that filing that it voluntarily withdrew Simcor and Advicor from the market and discontinued distribution as of 31 December 2015.
FDA based its decision to call for the removal of the NDAs and prevent the marketing of generics for Simcor and Advicor on three studies published in the New England Journal of Medicine in 2010, 2011 and 2014. The 2011 study was funded in part by Abbott Laboratories, the company that created AbbVie in 2012.
The 2011 study concluded: “Among patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter (1.81 mmol per liter), there was no incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period, despite significant improvements in HDL cholesterol and triglyceride levels.”
Advicor was first approved by FDA in 2011, while Simcor was first approved in 2008.
AbbVie Spokesman Morry Smulevitz told Focus that the drugs were voluntarily discontinued on 1 December 2015, "based on
discussions with the FDA regarding results of recent clinical trials which
overall did not demonstrate an incremental outcome benefit associated with the
co-administration of extended release niacin in combination with statin drugs
beyond treatment with statins alone in a patient population with well
controlled LDL and non-HDL. The discontinuation was not related to
the safety of either product, or the safety of the respective components of
each product. AbbVie took appropriate steps to inform prescribers, healthcare
professionals, pharmacies and patients of the decision to facilitate patient
transition to alternative therapies."
This is the second time this week that FDA has announced the withdrawal of an NDA due to efficacy concerns.
Federal Register: AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCOR