Dificid
Generic name: fidaxomicin
Treatment for: Clostridioides difficile Infection
Rolling NDA Submitted for Fidaxomicin
Optimer Pharmaceuticals Submits Rolling New Drug Application to FDA for Fidaxomicin
SAN DIEGO, Sept. 21 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.
"With our NDA submission underway, we continue on the path of bringing this much needed therapy to CDI patients," said Pedro Lichtinger, President and CEO of Optimer. "CDI is a serious health threat and the incidence of the infection continues to increase. We believe fidaxomicin may become the best therapeutic option for this critical illness and we look forward to its commercialization, if approved."
Fidaxomicin received Fast Track designation from the FDA in 2003 for the treatment of CDI. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The rolling submission process enables companies that have been granted Fast Track designation by the FDA to submit completed sections of its NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.
About Fidaxomicin
Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile. The narrow-spectrum profile of fidaxomicin may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics used to treat CDI, metronidazole and vancomycin, disrupt the flora. Fidaxomicin may facilitate the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence.
About Clostridium difficile Infection (CDI)
CDI has become a significant medical problem in hospitals, long-term care facilities, and in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produces toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, and thus allowing C. difficile bacteria to flourish.
Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the only FDA-approved treatment. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration.
Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), advanced age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. Increasing incidence, higher treatment failures and recurrence with current therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials. Learn more about CDI at www.cdiinfo.org.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development. Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). Optimer has completed two Phase 3 trials of fidaxomicin for the treatment of CDI, demonstrating that fidaxomicin was statistically superior to vancomycin in global cure rate (defined as cure with no recurrence within four weeks of completing therapy) as well as statistically superior in reducing recurrences of CDI by up to 50% when compared with vancomycin, the only FDA approved product for CDI. Optimer has also successfully completed two Phase 3 trials of Pruvel™ a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Forward Looking Statements
Statements included in this press release that are not a description of historical facts are forward looking statements, including without limitation all statements related to the development of fidaxomicin, the timing of NDA submissions, Optimer's plans to request priority review, anticipated timing of the FDA's review of Optimer's NDA submissions, the incidence and effects of CDI, the efficacy of current CDI treatments and the efficacy and potential benefits of fidaxomicin, potential regulatory approval of fidaxomicin, Optimer's plans to commercialize fidaxomicin, if approved, and the awareness of CDI among healthcare professionals. Words such as "believes", "would", "anticipates", "plans", "expects", "may", "intend", "will", and similar expressions are intended to identify forward looking statements. The inclusion of forward looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the development of alternative treatments for or means of preventing CDI, whether regulatory authorities will review or approve Optimer's applications for marketing approval within Optimer's anticipated timelines or at all, the timing of any marketing approvals, Optimer's ability to complete its NDA submission in a timely manner, Optimer's ability to commercialize any products for which it receives marketing approval, whether healthcare professionals will prescribe fidaxomicin, if approved, whether fidaxomicin will receive reimbursement coverage from healthcare payors and government agencies and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
Contacts
Optimer Pharmaceuticals, Inc.
Christina Donaghy, Corporate Communications Manager
John D. Prunty, Chief Financial Officer & VP Finance
858-909-0736
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
619-849-6005
SOURCE Optimer Pharmaceuticals, Inc.
Posted: September 2010
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Dificid (fidaxomicin) FDA Approval History
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