Teva Pharmaceuticals’ Austedo (deutetrabenazine tablets) has been approved by China’s National Medical Products Administration (NMPA) for treating chorea associated with Huntington’s disease and tardive dyskinesia in adults.
As part of its expedited review process for medicines, the NMPA granted Austedo priority review and added the therapy to the “List of Overseas New Drugs Urgently Needed in Clinical Settings,” which facilitates the review and approval of overseas therapies urgently needed in clinical settings. China is the second country, after the U.S., to approve Austedo.
“The approval of Austedo in China is an exciting milestone for Teva,” Gianfranco Nazzi, executive vice president at Teva, said in a press release. “We are delivering on our mission to improve patients’ lives by offering a new treatment option for conditions where the unmet need is significant.”
Chorea — brief and abrupt involuntary movements — occurs in around 90% of Huntington’s patients. These movements can be confined to a single area in the body or appear to flow from one body part to another, and can interfere with speech, swallowing, posture, and walking.
Austedo binds and blocks a protein called vesicular monoamine transporter 2 (VMAT2), reducing the amount of the neurotransmitter dopamine released from nerve cells, preventing the overstimulation of muscles that causes chorea.
An alternative therapy to Austedo is the FDA-approved therapy called Xenazine (tetrabenazine), also a VMAT2 blocker. While both reduce chorea in Huntington’s patients, Austedo has a longer half-life, meaning it degrades more slowly than Xenazine, prolonging its effects.
Austedo’s ability to reduce chorea in Huntington’s disease patients was assessed in a placebo-controlled Phase 3 clinical trial (NCT01795859).
Patients were treated with increasing doses to achieve an optimal study dose level over eight weeks, followed by a four-week maintenance period, then a week of no medication.
Results revealed that Austedo significantly reduced the total maximal chorea (TMC) scores from baseline to 12 weeks. However, after a week of no treatment, TMC scores reverted back to their initial values.
The most common side effects reported were sleepiness, diarrhea, dry mouth, and fatigue. Austedo is not recommended for people with a liver condition or those treated for depression with medicines called monoamine oxidase inhibitors.
Austedo’s approval in China is the second for a Teva specialty medicine where they will independently commercialize the therapy.
This is the second approval and expected launch in China of a Teva specialty medicine. Teva will commercialize Austedo in China independently.
“We look forward to bringing more of the essential medicines in our portfolio to patients in China, and to fuel organic growth and expand our presence in this important market,” Nazzi said.
Austedo also is approved for tardive dyskinesia, a movement disorder characterized by uncontrollable movements of the face, trunk, and extremities caused by long-term use of neuroleptic medications, often prescribed for management of certain mental, neurological, or gastrointestinal disorders.
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