Published on March 2, 2010 at 12:00 AM
ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that its
investigational pan-BCR-ABL inhibitor, AP24534,
has been granted orphan drug designation by both the U. S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA). In the
U.S., the orphan designation of AP24534 is for the treatment of chronic
myeloid leukemia (CML) and Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL) and in the E.U., its orphan designation
is for CML and acute lymphoblastic leukemia.
“While impressive medical gains have been made over the past decade in
treating various forms of leukemia, it is clear that the disease can be
severe and life-threatening when it progresses”
“While impressive medical gains have been made over the past decade in
treating various forms of leukemia, it is clear that the disease can be
severe and life-threatening when it progresses,” said Frank Haluska,
M.D., Ph.D., vice president, clinical affairs of ARIAD. “Orphan drug
designation for AP24534 highlights the lack of therapeutic options
available for patients with CML or Ph+ ALL, who are resistant or
refractory to currently available therapies. We expect to advance
AP24534 into a pivotal registration trial later this year and pursue
subsequent regulatory submissions for marketing authorization in these
hematological cancers.”
Orphan drug designation, which is intended to facilitate drug
development, provides substantial potential benefits to the sponsor,
including funding for certain clinical studies, study-design assistance,
and several years of market exclusivity for the product upon regulatory
approval.
Source ARIAD
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Posted in: Medical Condition News | Pharmaceutical News
Tags: Acute Lymphoblastic Leukemia, Angiogenesis, Bone, Bone Marrow, Cancer, Cell, Chemotherapy, Chromosome, Chronic Myeloid Leukemia, Leukemia, Myeloid Leukemia, Oncology