By Razak Musah Baba
LONDON--AstraZeneca PLC's (AZN.LN) selumetinib drug has been
granted a special status by the U.S. Food and Drug Administration
for treatment of Uveal melanoma, a rare eye disease.
The biopharmaceutical firm said Friday the FDA has granted
'Orphan' drug status to selumetinib for the treatment of Uveal
melanoma, a rare disease in which cancer cells form in the tissues
of the eye.
The 'Orphan' status is granted to drugs and biologics intended
for the safe and effective treatment, diagnosis or prevention of
rare diseases or disorders that affect fewer than 200,000 people in
the U.S.
AstraZeneca acquired exclusive worldwide rights to selumetinib
from Array BioPharma Inc in 2003.
Selumetinib, inhibits the MEK pathway -- a chain of
communication proteins -- in cancer cells to prevent the tumor from
growing.
AstraZeneca also said Friday that data from a phase III study
evaluating selumetinib in combination with chemotherapy in patients
with first-line metastatic uveal melanoma is expected to be
available later this year.
In addition to uveal melanoma, selumetinib is being investigated
in Phase III studies in KRAS mutation positive lung cancer and
thyroid cancer and in Phase II in children with neurofibromatosis
Type 1, the company added.
At 1005 GMT AstraZeneca shares traded up 9 pence, or 0.1%
higher, at GBP48.43, valuing the FTSE 100 pharmaceutical company at
GBP61.15 billion.
Write to Razak Musah Baba at razak.baba@wsj.com; Twitter:
@Raztweet
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