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New Drug Reduced ‘Bad’ Cholesterol in Nine Late-Stage Trials

Update Date: Jul 30, 2014 09:18 AM EDT

The late-stage trials' results of a new cholesterol drug were promising, researchers reported. The drug, created by French company Sanofi and its U.S. partner, Regeneron, was capable of cutting low-density lipoprotein (LDL) cholesterol levels, which is commonly called bad cholesterol.

The drug, alirocumab, is an injectable drug that belongs to a new class of medicines known as PCSK9 inhibitors. Other drugmakers, such as Amgen Inc., are also developing these types of drugs. PCSK9 inhibitors work by blocking a protein that prohibits the body from getting rid of the LDL cholesterol present in the bloodstream.

In the nine Phase III ODYSSEY trials, the researchers found that alirocumab helped reduce LDL cholesterol levels after 24 weeks of treatment. The mean percentage reduction in these levels was consistent with the results found in earlier trials. The trials had included people with elevated LDL cholesterol levels who did not respond to current treatments, such as statins.

"The robust data from these studies in more than 5,000 patients is the basis of our global regulatory submissions, which we expect in the U.S. and EU by year-end," said Sanofi R&D chief Elias Zerhouni according to Reuters.

"Clinical data to date show consistent, positive results in LDL-C lowering, with an encouraging safety and tolerability profile across all Phase 3 alirocumab trials that we have reported," George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories added reported by the Wall Street Journal. "Importantly, in the trials that used an individualized approach with 75 mg and 150 mg doses, the majority of patients reached their LDL-C goal while remaining on a 75 mg dose. This dosing approach was designed to provide physicians and patients with the flexibility to tailor therapy to patients' lipid-lowering needs."

The companies stated that in earlier mid-stage trials when the drug was used in combination with statins, the treatment was capable of cutting cholesterol levels by almost 70 percent. Throughout the trials, the drug was "generally well tolerated." The most common side effects were nasopharyngitis, upper respiratory tract infections and reactions at the injection site. Serious side effects included musculoskeletal, neurocognitive and liver-related complications, and death.

The drug's ability to cut cardiovascular risk is currently being tested in a long-term outcomes trial involving 18,000 patients.

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