UPDATE 1-FDA reviewers unconvinced on Teva Parkinson’s drug
By Alina SelyukhOct 13 (Reuters) - Teva Neuroscience Inc’s
clinical trials of its Parkinson’s drug Azilect left U.S. drug
reviewers unconvinced that the treatment slows the disease’s
progression.In documents released on Thursday, Food and Drug
Administration researchers raised concerns about the design of
the studies, their analysis and results.They added, however, that, “it has not been clear what sort
of data would definitively establish” whether a drug modifies
the disease.”There is no demonstrated benefit of rasagiline (Azilect’s
generic name) for slowing the rate of progression of
Parkinson’s Disease,” one reviewer wrote.Azilect, which Teva markets alongside Danish partner
Lundbeck in a number of countries, is approved to
treat symptoms of the neurological disorder, such as trembling
limbs, stiffness, slow movement and impaired balance.The Israel-based drugmaker wants to expand the drug’s
indication to show that Azilect slows the clinical progression
of Parkinson’s.There is no existing cure or treatment that slows or
entirely stops the progression of Parkinson’s.The review was also complicated by the fact that it is hard
to draw a line between treating the symptoms of Parkinson’s and
treating the disease.Much is unknown about Parkinson’s, including the causes of
the neurogenetic disorder. Anywhere from 500,000 to 1.5 million
Americans are estimated have the disease, and nearly 60,000 are
diagnosed each year, according to Parkinson’s Action Network.Azilect received FDA approval in 2006 for use as a single
drug therapy in early Parkinson’s and, in more advanced
patients, as addition to levodopa, a standard treatment for the
disease that can mask symptoms of the disease, but does not
stop its progression.Teva’s drug works by blocking the breakdown of dopamine, a
chemical that sends information to the parts of the brain that
control muscle movement and coordination.FDA advisers will vote on Oct. 17 on whether Teva has
provided the drug regulator with enough evidence of Azilect
slowing down Parkinson’s.