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【其他】美国FDA AIDAC推荐批准Optimer 的非达米星（fidaxomicin）用于CDI治疗
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美国FDA AIDAC全票通过推荐批准Optimer Pharmaceuticals公司的非达米星（fidaxomicin）用于CDI治疗 2011年4月5日，Optimer Pharmaceuticals公司宣布，美国FDA(U.S. Food and Drug Administration)下属抗感染药物顾问委员会（Anti-Infective Drugs Advisory Committee (AIDAC)）以13:0的投票结果推荐FDA批准Optimer公司在研新型抗生素DIFICID™(非达米星，fidaxomicin)用于治疗艰难梭菌感染（Clostridium difficile infection (CDI)），而FDA要在2011年5月30日就《处方药使用者付费法案》（The Prescription Drug User Fee Act，PDUFA）做出审批结论。 OPTIMER ANNOUNCES THAT THE U.S. FOOD AND DRUG ADMINISTRATIONS ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE VOTED UNANIMOUSLY TO RECOMMEND APPROVAL OF NOVEL ANTIBIOTIC DIFICID FOR TREATMENT OF PATIENTS WITH CLOSTRIDIUM DIFFICILE INFECTION (CDI) Optimer to host conference call for investors on April 6 at 8:00 a.m. Eastern Time San Diego, CA – April 5, 2011 – Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) recommended that the FDA approve Optimer’s investigational antibiotic DIFICID™(fidaxomicin) for the treatment of patients with Clostridium difficile infection (CDI), a bacterial infection in the lining of the gut that can cause severe diarrhea, colitis and in some cases death. In a unanimous 13-0 decision, the AIDAC found that the clinical evidence submitted by Optimer demonstrated the safety and effectiveness of DIFICID for the treatment of CDI. “We view the vote of the FDA’s panel of expert advisors, with diverse backgrounds ranging from infectious disease to biostatistics, as a strong endorsement for approving DIFICID for the treatment of CDI. We are encouraged that the advisory committee recognizes the urgent need for new treatment options for CDI and the seriousness of the increasing incidence of these infections,” said Pedro Lichtinger, President and CEO of Optimer. “We are proud to be one step closer to providing patients, healthcare providers and physicians with a new treatment option for CDI, a serious and debilitating disease that can impact every aspect of a patient’s life.” The FDA is not bound by the committee’s guidance but takes its advice into consideration. Optimer submitted its New Drug Application (NDA) for DIFICID on November 30, 2010. The FDA accepted the DIFICID NDA filing and granted a six-month Priority Review in January 2011, assigning a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. “In Phase 3 clinical studies, DIFICID was proven to be as effective as vancomycin in clinical cure, and was superior to vancomycin in global cure, defined as cure without a recurrence after 4 weeks of therapy. The advisory committee referred to the global cure outcome as 30-day resolution, which we believe is indicative of DIFICID’s benefit in reducing recurrences,” said Sherwood Gorbach, M.D., Optimer’s Chief Medical Officer. “While the advisory committee vote was split on how best to describe the recurrence benefit, the committee members overwhelmingly recognized that DIFICID at 30 days was superior to vancomycin. We appreciated the committee’s discussion and look forward to working with the FDA as it considers our DIFICID NDA.” The AIDAC based its decision in part on the review of clinical evidence from the two largest, comparative Phase 3 clinical trials ever conducted against vancomycin in CDI. These multi-center, randomized, double-blind trials enrolled a total of 1,164 adults with confirmed CDI, who received either DIFICID (200 mg q12h) or vancomycin (125 mg q6h), the only FDA-approved product for the treatment of CDI. The objective of both studies was to show that a 10-day course of DIFICID was at least as efficacious (non-inferior) and safe as a 10-day course of vancomycin for the treatment of CDI. In both studies, DIFICID demonstrated a statistically significant reduction in the rate of recurrence compared with patients treated with vancomycin, reducing CDI recurrences by 47 percent, and was statistically superior to vancomycin in global cure rate (clinical cure without disease recurrence within four weeks). In addition, DIFICID met the primary endpoint of non-inferiority of clinical cure (defined as patients requiring no further CDI therapy two days after completion of study medication) compared to vancomycin. DIFICID was safe and well tolerated in both studies, showing a similar incidence of treatment-related adverse events when compared to vancomycin. Scheduled Conference Call Optimer will host a conference call tomorrow at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial (877) 280-7280 from the U.S., or (678) 825-8232 for international callers. Please specify to the operator that you would like to join “Optimer’s Conference Call.” The conference call will be webcast live under the Investors section of Optimer’s website at www.optimerpharma.com, where it will be archived for 30 days following the call. Please connect to Optimer’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. About DIFICID™ (Fidaxomicin) DIFICID™ (fidaxomicin) is a new antibiotic with a novel mechanism of action, which inhibits the bacterial enzyme RNA polymerase, resulting in the rapid killing of C. difficile. The narrow-spectrum profile of DIFICID eradicates C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics used to treat CDI, metronidazole and vancomycin, have been shown to disrupt the gut flora. DIFICID facilitates the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence rates. In two Phase 3 trials for the treatment of CDI, DIFICID was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. DIFICID also demonstrated statistically significant reduction in recurrences and an increase in global cure rate, defined as cure without recurrence. Importantly, DIFICID reduced the risk of recurrence by 47% compared to vancomycin. The New England Journal of Medicine has published results from the first Phase 3 trial in an article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile Infection,” which appeared in the February 3, 2011 issue. |
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