Regulatory Teva secures FDA approval for its medication Austedo

Teva secures FDA approval for its medication Austedo


Teva has been keen to reduce the number of tablets patients need to take in half, understanding the difficulties faced by those who suffer from chorea, tardive dyskinesia (TD), and Huntington’s disease (HD). The FDA has now given the company the go-ahead to do that.

The regulatory authority approved Teva’s Austedo extended-release tablets in 6, 12, and 24 mg dosages amid a flurry of approvals, setting up a once-daily version of the medication that for the first time can also be taken without meals. The new formulation claims therapeutic equivalent to its twice-daily predecessor, which received its first approval in 2017.

According to Sven Dethlefs, EVP at Teva’s for North American marketing, Austedo is an essential part of the company’s central nervous system disease line and one of the most significant molecules in the market. The company claims that this approval is a revolutionary step for both the company and patients.

Movement disorders like TD and HD are frequently co-occurring illnesses that require a high number of medicines. According to Dethlefs, this in turn makes it challenging to take prescribed medications as directed. Teva claims that Austedo provides a solution to lighten that weight.

Whereas TD is a movement disorder characterised by uncontrolled and repeated motions of the face, chest, and other body parts, chorea linked with HD refers to involuntary jerking or writhing movements in Huntington’s disease patients. 

Teva claims that 1 in 4 patients receiving certain mental health medicines get TD. According to Dethlefs, it frequently results from another underlying illness like schizophrenia combined with years of antipsychotic medication therapy. A once-daily formulation that is considerably simpler to take in the morning or evening is unquestionably a step in the right direction for the patients.

According to the CEO, Teva intends to introduce Austedo XR in the first half of 2023 after receiving permission. The business will use its well-established CNS salesforce to reach out to neurologists and psychiatrists at long-term care institutions in order to spread the word about its new daily medication offering. In the CNS sector, Teva employs roughly 400 sales representatives.

Also, according to Dethlefs, Teva plans to launch a marketing effort to inform consumers of the differences between Austedo traditional and the new formula medication.

Teva is still confident in Austedo’s potential ability in the treatment of TD, the primary indication for the drug that is thought to impact 785,000 Americans. Dethlefs stated that the illness is underdiagnosed and undertreated, leading to filling the market gap and potential growth for Teva’s medication.

Dethlef stated:

“The Israeli-American company is actively working with prescribers to tackle the challenge of TD diagnosis and treatment trends, describing Teva’s Austedo work as a long-term commitment to the field. Our commitment to patients suffering from these diseases is unwavering, and we will continue our mission to address the needs of patients with neurodegenerative disorders.”

Teva anticipates that its VMAT2 inhibitor will generate sales of about $1.2 billion this year.

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