Date: 0000-00-00
Type of information: Submission of an NDA
Product name: rasagiline mesylate
Compound: rasagiline mesylate
Therapeutic area: Neurological diseases - CNS diseases
Action mechanism:
- Rasagiline is a monoamine oxidase B (MAO-B) inhibitor.
- By irreversibly binding to MAO-B, it prevents the breakdown of dopamine in the brain, increasing the levels of dopamine within the synaptic cleft, thus providing beneficial effects on Parkinson’s disease symptoms. Currently, rasagiline mesylate is approved in 55 countries including the US, Canada, Israel, Mexico, and European countries. Both monotherapy and combination therapy with levodopa are approved as treatment of Parkinson’s disease overseas. Rasagiline mesylate can be used in combination with dopamine agonist, without levodopa, in the US.
- Teva developed this product and received its first approval in 2005 in Israel and Europe. Teva and Takeda signed an agreement in 2014, granting Takeda a right for commercialization and clinical development of rasagiline mesylate in Japan.
Company: Takeda Pharmaceutical (Japan)
Disease: Parkinson’s disease
Latest news:
- • On June 29, 2017, Takeda Pharmaceutical announced that it has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for rasagiline mesylate for the treatment of Parkinson’s disease.
- The NDA was filed based mainly on the result of the Phase 2/3 clinical trial (Study CCT-002) and the Phase 3 clinical trial (Study CCT-001), conducted in Japan. Study CCT-002, conducted in patients with Parkinson’s disease under the treatment with levodopa, and Study CCT-001, conducted in patients with early stage Parkinson’s disease demonstrated efficacy of the drug without major safety concerns.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
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UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
