CHMP Recommends Astellas Pharma Europe Ltd.’s (APEL) DIFICLIR(TM) for Approval in the EU
STAINES, England and SAN DIEGO, California, September 23, 2011 /PRNewswire/ –
Astellas Pharma Europe Ltd. (APEL) and Optimer Pharmaceuticals, Inc.
(NASDAQ: OPTR) today announced that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion for DIFICLIR(TM) (fidaxomicin) tablets for the treatment of
adults suffering with a Clostridium difficile infection (CDI), also known as
C. difficile-associated diarrhoea (CDAD).
The CHMP positive opinion is based on Phase 3 clinical studies that were
conducted to compare the safety and efficacy of 400mg/day fidaxomicin with
500mg/day oral vancomycin for 10 days in subjects with CDI. The first
Phase 3 study was carried out in 629 subjects in North America (US and
Canada). The second Phase 3 study was carried out in 535 subjects in
North America and Europe. The results of the studies showed that the
proportion of subjects in which clinical cure* was achieved at the end of 10
days of treatment, were similar for both treatments, thus fidaxomicin met
its primary endpoint of non-inferiority to vancomycin. Furthermore in
both trials, fidaxomicin had a significantly lower rate of recurrence of CDI
compared to vancomycin.
“European patients with this potentially fatal disease can take
encouragement from the positive CHMP opinion for DIFICLIR that a new
medication for Clostridium difficile infection may soon be available,” said
Ken Jones, President and CEO of Astellas Pharma Europe Ltd.
DIFICLIR, which is known as DIFICID(TM) in the United States (US), was
approved by the US FDA in May 2011 for the treatment of CDAD in adults 18
years of age and older.
The European Commission generally follows the recommendations of the
CHMP and delivers its final decision within three months.
DIFICLIR is a novel macrocyclic antibiotic that specifically targets C.
About Clostridium Difficile Infection (CDI)
CDI is a serious illness resulting from infection of the internal lining
of the colon by C. difficile bacteria. The bacteria produce toxins that
cause inflammation of the colon, diarrhoea and, in some cases, death.[7,8]
Patients typically develop CDI after the use of broad-spectrum antibiotics
that disrupt normal gastrointestinal flora, allowing C. difficile bacteria
to flourish. Older patients are at greater risk of CDI recurrence
specifically those aged 65 years of age or older.
About Astellas Pharma Europe Ltd.:
Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary
of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceuticals. The organisation is
committed to becoming a global company by combining outstanding R&D and
marketing capabilities and continuing to grow in the world pharmaceutical
market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices
located across Europe, the Middle East and Africa, an R&D site and three
manufacturing plants. The company employs approximately 4,000 staff across
these regions. For more information about Astellas Pharma Europe, please
visit http://www.astellas.eu/ [http://www.astellas.eu ].
About Optimer Pharmaceuticals, Inc.:
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on
discovering, developing and commercialising hospital specialty products to
treat serious infections and address unmet medical needs. Optimer has a
further anti-infective product in development. Additional information can be
found at http://www.optimerpharma.com/ [http://www.optimerpharma.com ].
1. Awaiting confirmation of CHMP approval
2. Louie TJ, Miller MA,
Mullane KM, et al. Fidaxomicin versus vancomycin for Clostridium difficile
infection. N Engl J Med. 2011;364:422-31.
3. Data on file: Crook et al ECCMID 2010.
4. Mullane KM, Gorbach S. Fidaxomicin: first-in-class macrocyclic
antibiotic. Expert Rev Anti Infect Ther. 2011;9:767-77.
5. Food and Drug Administration. FDA approves treatment for Clostridium
difficile infection [Internet]. [updated May 27 2011; cited September 16
2011] Available from
6. DIFICID US Prescribing Information 2011.
7. Gerding DN, Johnson S, Peterson LR, et al. Clostridium
difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol.
8. Sunenshine et al. Clostridium difficile-associated disease: New
challenges from an established pathogen. Cleve Clin J Med 2006;73:187-97.
9. Kelly CP, LaMont JT. Clostridium difficile infection. Annu Rev Med.
10. Pepin, J et al. Increasing Risk of Relapse after Treatment of
Clostridium difficile Colitis in Quebec, Canada. Clin Infec Diseases, Oxford
*Please note: clinical cure was defined in these two clinical trials as
patients requiring no further CDI therapy two days after completion of study
medication, as determined by the investigator.
SOURCE Astellas Pharma Europe Limited