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U.S. FDA panel rejects Novartis drug for gout
June 21, 2011 / 8:13 PM / in 6 years

U.S. FDA panel rejects Novartis drug for gout

COLLEGE PARK, Maryland (Reuters) - An advisory panel on Tuesday rejected a Novartis AG drug for gout over concerns about side effects, a setback for the company’s efforts to expand use of the medicine.

<p>Pigeons sit on a roof in front of the logo of Swiss drugmaker Novartis at the company's plant in Basel January 28, 2009. REUTERS/Arnd Wiegmann</p>

A committee of Food and Drug Administration advisers voted 11-1 against recommending approval of the drug for treating attacks of gout, a common form of inflammatory arthritis that affects about 8.3 million U.S. adults.

The panel also unanimously voted against the drug, under the proposed trade name Ilaris, for delaying and reducing the frequency of future attacks.

Most advisers said the drug was effective in company studies of gout patients. But it also was linked to higher rates of serious infections and other potential side effects.

Advisers also focused on the lack of long-term data. In a company study, out of 454 patients only 43 had three or more injections of Ilaris, making it difficult to measure the effects of the drug over time.

“I found the safety issues to be overwhelmingly concerning,” said Dr. David Felson, a panel member and professor of medicine and epidemiology at the Boston University School of Medicine.

“We’re giving therapies that in some cases may be life-threatening for a disease that is not. Forty-three patients with recurrent treatment is too small a number for us to be confident that this would be safe for people over time.”

Gout is a type of arthritis that occurs when uric acid builds up in the joints, often causing chronic pain and joint destruction. Typically one or a few joints are affected such as the big toe or ankle.

Ilaris, which blocks a protein that is thought to increase inflammation, is already sold for treating a rare inflammatory disorder. Novartis has predicted the drug could generate blockbuster sales if it won clearance for gout and juvenile rheumatoid arthritis.

Deutsche Bank analyst Richard Parkes last week estimated “relatively modest sales” of Ilaris in gout reaching $510 million in 2016 if the drug is approved.

The FDA usually follows panel recommendations. The agency is due to make a decision on the drug by year-end, Novartis said.

DRUG IS NOT FOR ALL

In the company’s study, almost 70 percent of patients had some mild to moderate side effects, including high blood pressure.

Eighteen patients of the 454 in the study had serious side effects such as skin, respiratory and other infections, including six patients who died. However, Novartis said none of the serious side effects were related to the drug as many patients already had pre-existing medical conditions.

Panelists suggested the drug could be useful for patients who cannot use other forms of anti-inflammatory treatment such as steroids to treat chronic acute attacks of gout.

However, they said more data was needed, as the company study did not include enough such patients, who are often older and also have diseases such as kidney or heart problems.

“There is no question in my mind that the risk would not outweigh the benefit in a niche population for patients who really have no alternatives available to them,” said Dr. Allan Gibofsky, a panel member and professor of medicine and public health at Cornell University. Gibofsky voted for approval.

“But I’d want some clarification and restrictive labeling.”

Novartis said it continues to believe in the benefits of Ilaris “and will work closely with the FDA to identify the right patient population who will benefit from this therapy,” Trevor Mundel global head of development at Novartis said in a statement.

Novartis shares ended 0.4 percent higher at $60.68 on the New York Stock Exchange, similar to a 0.5 percent gain in the Arca Pharmaceutical Index.

Reporting by Anna Yukhananov, additional reporting by Lisa Richwine; Editing by Carol Bishopric

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