The Burrill Report


Idenix Pharmaceuticals said that the U.S. Food and Drug Administration placed a clinical hold on the development of another one its experimental hepatitis C drugs. The FDA is barring Idenix from testing IDX19368 in humans. The FDA had already halted trials of Idenix’s hepatitis C drug IDX184 due to concerns over heart damage. Earlier this month, the FDA stopped a clinical trial of Bristol-Myers Squibb’s hepatitis C candidate drug BMS-9860944 after the company reported that one patient in clinical trials had died of heart failure following treatment. Bristol-Myers Squibb has since said that it is abandoning development of the product all together. Like BMS’ failed compound, Idenix’s two experimental hepatitis C drugs are nucleotide inhibitors, designed to prevent the hepatitis C virus from replicating, causing investor pessimism. Since Idenix’s IDX184 trial was halted in mid August, the company’s shares have slipped 31.8 percent.

The U.S. Food and Drug Administration said that a post-approval study of Vertex Pharmaceuticals’ Kalydeco in rats showed the development of cataracts, and said it is concerned about the potential development of cataracts in children being treated with the cystic fibrosis drug. Because eye development in humans is different than in rats, there is uncertainty about what the data actually means, but the FDA is still requiring that Vertex conduct a two-year clinical trial in children up to age 11 who are being treated with Kalydeco to see if they develop cataracts as well. Information from the rat study is also being added to Kalydeco’s label. A Vertex spokesperson said that the company has not received any reports of cataracts among patients being treated with the drug since its approval last year nor has it seen any development of cataracts in patients who were part of the Kalydeco clinical studies.

Sanofi’s rare disease division Genzyme voluntarily recalled nine lots of its drug Thymoglobulin, which is used to treat transplant rejection in kidney transplant patients. The recall was first initiated on August 2 when one of the Thymoglobulin lots failed a periodic stability test, an examination of the shelf life of a drug within specified conditions. A notice on the U.S. Food and Drug Administration’s website said “Genzyme has not identified any new safety risk to patients who have received Thymoglobulin from the implicated lot numbers, and there are no confirmed safety issued directly associated with the stability failure.” The raw material used to produce the drug has been considered as the reason for the change in the shelf life of Thymoglobulin.

Eli Lilly’s new heart drug Effient failed to beat Plavix in a comparison study, likely dashing expectations for Effient’s expanded use in treating less-critically ill heart patients. Lilly and its development partner Daiichi Sankyo had hoped to prove that Effient was a better option for patients with acute coronary syndrome but the 9,000 patient study found that there was no difference between Effient and Plavix in preventing heart attacks, strokes and deaths. The study, however, did find that there was a lower risk of adverse events in patients on Effient after 12 months of treatment, but the trend was not conclusive and further exploration of the finding would be necessarily to validate the trend.

U.S. Food and Drug Administration regulators have recommended against the use of Pfizer’s pulmonary arterial hypertension drug, Revatio, in children up to 17 years of age. Though the drug has been approved by the FDA for the treatment of PAH in children, the warning is against the off-label use of the drug, or more specifically high dose usage of the drug. The FDA made the recommendation against the high dose use of Revatio based on a recent post-approval clinical trial and has added the warning to Revatio’s drug label.


August 31, 2012
http://www.burrillreport.com/article-fda_halts_idenix%e2%80%99s_second_hepatitis_c_drug_.html