Bayer, Algeta win FDA approval for prostate cancer drug
FRANKFURT (Reuters) - German drugmaker Bayer and its development partner Algeta won approval from U.S. regulators for a prostate cancer drug that could eventually generate more than 1 billion euros ($1.31 billion) in annual sales.
The Food and Drug Administration, which has reviewed Xofigo under its priority program, said on Wednesday the injection is cleared for treatment of bone metastases in men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
Bayer licensed Xofigo, also called radium-223 dichloride, from Norway's Algeta in 2009 and the two companies will co-promote the injection in the U.S.
Bayer has also requested approval for the drug in Europe, where it would market the drug alone.
The drug, which according to Bayer could become a "blockbuster" product with annual sales of least 1 billion euros, has some properties of calcium. That makes it cling to cancerous bone cells and then destroy them via alpha rays, which is more targeted than the shotgun approach of conventional radiotherapy.
($1 = 0.7641 euros)
(Reporting by Ludwig Burger; Editing by Louise Heavens)
- Pope attacks mega-salaries and wealth gap in peace message
- Air strike kills 15 civilians in Yemen by mistake: officials
- Probation for drunk Texas teen driver who killed four sparks backlash
- Atheists face death in 13 countries, global discrimination: study
- South Africa admits error over 'schizophrenic' Mandela signer |
Thousands line up to say goodbye to Nelson Mandela, whose body is lying in state in Pretoria. Slideshow