Teva Pharmaceutical said on Monday that China has given the go-ahead to its Austedo treatment for Huntington's disease.
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Israel-based Teva's Chief Executive Kare Schultz said Austedo would be priced somewhat lower in China, the world's second-largest drug market, than in the United States, which has already approved the drug.
However, it will not yet be eligible for coverage under China's national insurance scheme, which means it will only be affordable initially to a limited proportion of patients.
Austedo was included in China's fast-tracked approval channel as a rare disease treatment of "significant clinical advantage", completing the process in four months. China is the second country after the United States to approve Austedo.
Teva said the drug been approved in China to alleviate uncontrollable movements known as chorea in patients with Huntington's disease, a rare and fatal neurodegenerative disorder that often appears in middle age, and for tardive dyskinesia, a movement disorder that is usually the result of treatment with certain psychiatric medications.
Teva's Tel Aviv listed shares were up 3.8% at 1217 GMT following its announcement and up 4.2% in pre-market trading in New York.
Austedo, which is expected to generate U.S. sales of $650 million this year, costs around $60,000 annually per patient in the United States before insurance coverage, Schultz said.
Austedo needs to be significantly cheaper than $60,000 a year to be affordable to most patients in China, where major commercial insurance programs are yet to cover Huntington's disease, said Cao Xi, who runs "Hyacinth Care", a Shanghai-based non-profit organization dedicated to the disease.
"We would go in with a strategy of being in the specialized clinics first, so there would not be broad access in the beginning," Schultz told Reuters before the Chinese approval.
Annual treatment costs for Chinese patients were around 12,000 yuan ($1,687) on average in 2018, a survey by Hyacinth Care which involved about 360 participants who suffer from Huntington's disease, or carry a mutant gene related to the illness, found.
"If (the drug is) too expensive, we hope there could be some national medical insurance-related policies to help patients afford the drug," said Cao, who has a relative with Huntington's disease.
China has pledged to include more rare disease drugs in its central government-backed nationwide insurance scheme, which most patients, especially less affluent ones, rely on to pay drug bills.
"You start with a private launch... and then it's many years typically before you get into the national process," Schultz said. "You're talking about a launch which is basically not government-aid to begin with."
Teva said the Austedo approval was the second approval in China for one of its specialty medicine, adding that it will commercialize the medicine in China independently.
Austedo was approved in the United States to treat chorea associated with Huntington's disease and tardive dyskinesia in 2017. Revenues from sales of the drug in North America surged 64% to $122 million in the first quarter.
