WAYNE, N.J., Aug. 23, 2011 /PRNewswire/ — Bayer HealthCare
Pharmaceuticals, Inc. today announced that its investigational
compound radium-223 chloride, which is exclusively licensed from
Algeta ASA, has been granted Fast Track designation by the U.S.
Food and Drug Administration (FDA) for the treatment of
castration-resistant (hormone-refractory) prostate cancer in
patients with bone metastases.
Radium-223 chloride is an investigational agent and is not
approved by the FDA, the European Medicines Agency (EMA) or other
Health Authorities.
“We are pleased that the FDA has granted Fast Track designation
to radium-223 chloride,” said Kemal Malik, MD, Head of Global
Development and member of the Bayer HealthCare Executive Committee.
“This is an important milestone in the overall development of this
compound.”
Fast Track Designation in the United States
Fast Track is a process designed to facilitate the development,
and expedite the review of drugs to treat serious diseases and fill
an unmet medical need. Fast Track addresses a broad range of
serious diseases. Fast Track designation must be requested by the
drug company and can be initiated at any time during the drug
development process. Once a drug receives Fast Track designation,
early and frequent communication between the FDA and a drug company
is encouraged throughout the entire drug development and review
process. The frequency of communication assures that questions and
issues are resolved quickly, often leading to earlier drug approval
and access by patients.
About Radium-223 Chloride
Radium-223 chloride is an investigational pharmaceutical
containing an alpha-particle emitting nuclide in development for
cancer patients with bone metastases. In September 2009, Bayer
signed an agreement with Algeta ASA (Oslo, Norway) for the
development and commercialization of radium-223 chloride. Under the
terms of the agreement, Bayer will develop, apply for
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