Teva gains FDA approval for once-daily formulation of flagship drug Austedo

Attuned to the burdens of people living with Huntington’s disease (HD) chorea and tardive dyskinesia (TD), Teva has been eager to cut the amount of pills patients need to take in half. Now, it's scored an FDA approval to do just that.

Amid a flurry of approvals Friday, the U.S. regulator cleared Teva’s Austedo extended-release tablets in 6-, 12- and 24-mg doses, teeing up a once-daily formulation of the drug that—for the first time—can also be taken without food. The new formulation boasts therapeutic equivalence to its twice-a-day counterpart, which was first approved back in 2017.

Austedo is the crown jewel in Teva’s central nervous system disorders franchise as well as “one of the most important molecules that we have in the market,” Sven Dethlefs, Ph.D., Teva’s executive vice president of North American commercial, said in an interview ahead of the approval.

Friday’s green light marks a “significant step forward” in the Austedo saga for Teva as well as patients, he said.

People with movement disorders such as TD and HD often suffer from concomitant conditions that require them to take many pills. That in turn makes it tough to comply with medication requirements, Dethlefs explained. Now, Austedo XR offers a way to reduce that burden.

Chorea associated with HD refers to involuntary jerking or writhing movements in Huntington’s patients, while TD is a movement disorder marked by uncontrollable and repetitive movements of the face, torso and other body parts. According to Teva, TD affects 1 in 4 people who take certain mental health treatments. It’s often the outcome of another underlying disease such as schizophrenia plus multiple years of treatment with antipsychotic drugs, Dethlefs pointed out.

“A once-daily formulation, which is much easier to take in the morning or the evening, is of course a step forward with the patients,” he said.

With the approval in hand, Teva plans to launch Austedo XR in the first half of 2023, the executive said. To get the word out about its new once-a-day pill, the company will rely on its established CNS salesforce targeting neurologists and psychiatrists in long-term care facilities. Teva has about 400 sales reps in the market for CNS.

Further, Teva is angling to roll out an educational campaign about the differences between Austedo classic and the drug’s new formulation, Dethlefs said.


Teva continues to believe in Austedo’s “tremendous potential” in TD—its core indication—which is estimated to affect around 785,000 people in the U.S. The condition is underdiagnosed and undertreated, too, Dethlefs said, suggesting there’s room for Teva’s med to grow.

The Israeli-American company is actively working with prescribers to tackle the “challenge” of TD diagnosis and treatment trends, Dethlefs said, describing Teva’s Austedo work as a “long-term commitment to the field.”

For all of 2022, Austedo brought home $963 million, falling just short of the $1 billion blockbuster threshold. This year, Teva expects its VMAT2 inhibitor to pull down revenues of around $1.2 billion.