Teva Pharmaceuticals develops Azilect, approved by the FDA in 2006, to relieve motor symptoms and delay Parkinson’s progression.
Azilect improves the quality of life in patients with Parkinson’s
Teva Pharmaceuticalsa pharmaceutical company based in Israel, introduced Azilect (Rasagilin), a selective inhibitor of monoamineoxidase-b (MAO-B), for the treatment of Parkinson’s disease. Approved by the FDA In May 2006, this medicine delays the degradation of dopamine in the brain, a key neurotransmitter for movement control. The daily administration of 1 mg of Azilect relieves motor symptoms such as tremors, rigidity and slow movements, benefiting patients in early and advanced stages of the disease.
The development of Azilect marked a significant advance in the management of Parkinson, a neurodegenerative disease that affects millions of people in the world. Research, led by scientists from Technion – Technological Institute of Israelshowed that rasagilin not only improves motor function, but can also delay the progression of the disease when administered in initial stages. Clinical studies, such as the trial TEMPOshowed that patients treated with Azilect for six months presented a lower functional deterioration compared to those who received placebo.
Azilect’s approval by the FDA It was based on four clinical trials that included thousands of patients. One of these, a phase 3 study with 404 participants, Azilect evaluated as monotherapy in patients with early Parkinson. The results indicated a significant improvement in the scale Unified Parkinson’s Disease Rating Scale (UPDRS)with a worsening of less than one point in the group treated compared to almost four points in the placebo group. These data consolidated the effectiveness of the medication in the control of motor symptoms.
In addition to its use as monotherapy, Azilect is used as an adjunct therapy in patients receiving Levodopa, a standard treatment for Parkinson’s. In essays like LARGO y PRESTOwhich included 687 and 472 patients respectively, Azilect significantly reduced the daily “off” time, periods in which symptoms reappear due to the decrease in the effect of Levodopa. This ability to stabilize motor fluctuations improves the quality of life of patients.
Key data on Azilect and its impact on Parkinson
- Standard dose: 1 mg daily, with or without food, for monotherapy or adjuvant therapy.
- Global approval: Authorized in 37 countries, including USA, Canada and the European Union.
- Side effects: Headache, insomnia and orthostatic hypotension, usually mild.
- Clinical trials: Tempo, Largo and Presto demonstrated efficacy in motor symptoms and not engines.
- Contraindications: Do not use with other MAO inhibitors or in severe liver failure.
Azilect global impact on Parkinson’s treatment
Since its launch, Azilect has been marketed in 37 countries, consolidating itself as a key therapeutic option for Parkinson. In 2016, Teva recovered exclusive drug distribution rights, previously transferred to Lundbeckand reduced its price to match that of Rasagilin generic. This decision extended access to treatment, especially in competitive markets such as Spain, where Parkinson’s affects about 150,000 people.
Rasagilin acts by selectively inhibiting enzyme Ma-Bwhich breaks down dopamine in the basal ganglia of the brain. Unlike selegilin, another MAO-B inhibitor, Azilect does not produce amphetamine metabolites, reduces the risk of unwanted stimulating effects. This pharmacological advantage, together with its administration in a single daily dose, facilitates compliance with treatment by patients.
Azilect’s benefits are not limited to motor symptoms. Studies have shown that the medicine improves non -engines symptoms, such as fatigue, mild cognitive impairment and sleep disorders, which significantly affect the quality of life of patients and their caregivers. In the essay ADAGIOpublished in The New England Journal of Medicine In 2009, it was suggested that raz FDA He did not approve this indication in 2011 due to inconsistencies in dose results.
Azilect’s development is an example of Israel’s leadership in pharmaceutical innovation. Researchers like Moussa YouDIM y John Finberg of Technion collaborated with Teva to create a medicine that combines clinical efficacy with a favorable security profile. The most common side effects, such as headache and insomnia, are generally mild, although caution is recommended in patients with mild liver failure or who take certain medications, such as ciprofloxacin.
Israeli innovation in the fight against Parkinson
Parkinson’s disease, the second most common chronic neurological disease in older adults after Alzheimer’s, affects approximately 10 million people in the world. In Israel, where it is estimated that 25,000 people live with the disease, Azilect has strengthened the country’s position as a medical research center. The collaboration between Teva and the Technion It began in the 1990s, when rasagilin was identified as a promising compound after studying the structure of selegilin.
Preclinical tests in animal models, such as mice exposed to neurotoxin MPTPThey demonstrated that rasagillin protects dopaminergic cells, reducing biochemical and behavioral changes associated with Parkinson’s. These findings promoted clinical trials in humans, which began in Israel, Europe and the United States. The security of the medication was confirmed in studies with healthy and patient subjects, with side effects comparable to those of the placebo.
In 2005, Azilect received approval in Europe and Israel, followed by the authorization of the FDA In 2006. In the United States, where it is marketed under the name Agilectthe medicine has been adopted by neurologists for patients in different stages of the disease. The availability of generic versions since 2017 has further expanded its scope, although Teva It is still the main provider of the brand medication.
The impact of Azilect transcends the clinical, since it represents an achievement of the Israeli pharmaceutical industry in a global context. The ability to Teva To develop and market an innovative treatment, it reflects the country’s commitment to scientific research and medical care. As Parkinson’s prevalence increases due to population aging, medications such as Azilect will continue to play a crucial role in handling this disabling disease.
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