Israeli drugmaker Teva Pharmaceuticals, currently the biggest generic pharmaceuticals firm in the world, got a boost for its proprietary business yesterday after winning approval in the USA for Azilect, the first once-daily oral treatment for Parkinson’s disease.
The US Food and Drug Administration (FDA) cleared Azilect (rasagiline) as initial monotherapy in early-stage Parkinson’s, as well as in combination with the standard drug levodopa for more advanced cases of the disease. Teva said it would launch the product within the next eight to 10 weeks.
Azilect hit a few hurdles on the way to US approval, with the Food and Drug Administration (FDA) asking for additional data on the drug in August 2005, but is already on the market in Europe and under regulatory review in Canada.
In a statement following the approval, the FDA noted that an increase in skin cancer has been observed in patients involved in the Azilect trials, but there is no evidence to directly link the drug to these cases.
“It appears that compared to the general population, patients with Parkinson's disease have an increased risk for this form of skin cancer,” said the agency. Teva has agreed to carry out a post-marketing study of Azilect in order to address the question of whether or not the drug increases this risk. Meanwhile, the Israeli company is also conducting a large clinical study – called ADAGIO – to see whether Azilect can slow the progression of Parkinson’s disease.
Azilect is Teva’s second proprietary drug after Copaxone (glatiramer acetate) for multiple sclerosis, and the company has doubled the salesforce at its Teva neuroscience marketing subsidiary on Copaxone’s stellar growth and in anticipation of the addition of Azilect to its stable.
The development of Azilect is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Lundbeck and Teva. In the three major European markets, the UK, Germany and France Teva and Lundbeck co-promote Azilect. In the USA, Teva has an agreement to co-promote the drug with Eisai, although no decision on this has yet been taken.
Azilect is a second-generation selective irreversible monoamine oxidase type B (MAO-B) inhibitor that blocks the breakdown of dopamine, a substance in the brain needed to facilitate movement.
Parkinson's disease is a chronic, progressive, neurodegenerative disorder whose exact cause remains unknown. It is estimated that around 1.5 million people in the USA suffer from PD and, in 2005, global sales of drugs to treat the condition were about $3 billion.
“Parkinson's is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians' treatment options," said Steven Galson, head of the FDA's Center for Drug Evaluation and Research.