June 5, 2015 / 1:15 PM / 4 years ago

UPDATE 2-FDA staff: Sanofi/Regeneron drug lowers LDL, is well tolerated

(Updates with analyst comment)

By Toni Clarke

WASHINGTON, June 5 (Reuters) - An experimental drug made by Sanofi SA and Regeneron Pharmaceuticals Inc effectively lowers bad LDL cholesterol and is generally well tolerated, according to a preliminary review by the U.S. Food and Drug Administration.

The review was published on the FDA’s website on Friday ahead of a meeting next Tuesday of a panel of outside advisers who will discuss the drug and recommend whether it should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

The drug, Praluent, also known as alirocumab, is one of a new class of LDL-lowering drugs known as PCSK9 inhibitors. The committee on Wednesday will discuss another drug in the class, Amgen Inc’s Repatha.

If approved, the drugs are expected to generate annual sales of more than $2.5 billion each by 2020, according to Thomson Reuters data. Some analysts predict sales for the class rising to $20 billion by 2026.

The panel is being asked by the FDA to consider which patient sub-populations with high cholesterol would best be served by Praluent - for example, those with different degrees of cardiovascular risk, patients with family histories of high cholesterol and high triglycerides, or patients who are or are not also taking statins, another type of cholesterol drug.

The ability of a drug to lower LDL has been used by the FDA for two decades as a surrogate for its success in reducing the risk of heart attack and other cardiovascular events.

Several statin trials have shown cardiovascular benefits but not all LDL-lowering drugs have. Next week’s panel will be the first in many years to discuss the use of LDL as a surrogate measure for a new class of cholesterol drugs, the FDA said.

The FDA said it will not require a cardiovascular outcomes trial as a condition of approval of Praluent, though the companies are conducting them. Amgen said on Friday it just completed enrollment in a 27,500 patient outcomes trial of Repatha in combination with statin therapy.

“I think the committee and the FDA will be clearly grappling with issues related to which population do you use the drug in,” said Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic. “What the FDA is doing is providing early access to these medications prior to the completion of the outcomes trials, but they don’t want them used in everyone until we see the outcomes data.”

In an introductory memo to panel participants, Dr. James Smith, deputy director of the FDA’s division of metabolism and endocrinology products, said some patients will not take statins for a variety of reasons, even they can tolerate them with no side effects.

“Thus, one must consider whether labeling that specifically indicates a drug for ‘statin-intolerant patients’ could promote a condition that is not well-understood and encourage some patients to prematurely abandon statins, a class that has robustly established benefits on CV outcomes.”

A possible alternative, he said, would indicate the drug for use in combination with maximally tolerated statin therapy, recognizing that for some patients, maximally tolerated statin therapy may be no statin therapy at all.

Seamus Fernandez, an analyst at Leerink, viewed the FDA’s review as “bullish.” He said it suggests the likelihood of a broad approval.

Praluent is designed to be given in biweekly injections of 75 mg or 150 mg. Repatha is designed as a biweekly 140 mg injection or a monthly injection of 420 mg.

The FDA is due to decide on approval for Praluent by July 24 and on Repatha by Aug. 27.

Reporting by Toni Clarke in Washington; Editing by Doina Chiacu and Steve Orlofsky

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