Viatris Korea said it launched Dovprela (ingredient: pretomanid), a drug-resistant tuberculosis (TB) treatment, in January.
Dovprela was developed by the TB Alliance, a non-profit organization that develops and delivers new TB treatments. The drug is produced and distributed through a global partnership with Viatris.
Dovprela received the permit from the Ministry of Food and Drug Safety in October 2021 as a three-drug regimen of bedaquiline, pretomanid, and linezolid (BPaL) for treating adult patients with extensive drug-resistant TB and treatment-resistant or non-responsive multidrug-resistant TB.
The drug started receiving health insurance benefits on Jan. 1 and will cost 74,205 won ($60) per dose with reimbursement.
Dovprela 200mg, bedaquiline 400mg, and linezolid 1,200mg are administered orally once a day for 26 weeks.
However, bedaquiline is administered orally once a day for two weeks, followed by administration of 200mg three times a week for 24 weeks with an interval of at least 48 hours between administrations. In the case of linezolid, if adverse reactions due to known toxicity occur, hospitals will reduce the dose to 600 mg and then to 300 mg or discontinue administration.
Dovprela reduced the treatment period from 18-20 months to 5-6 months thanks to its rapid anti-tuberculosis effect, Viatris said.
Also, the drug reduced the number of medications needed from at least five to three, and the cure rate can be expected to be higher than before, the company said.
“It is significant that Dovprela was released as a reimbursed drug in Korea, where there is still a high unmet medical demand for TB management,” said Lim Hyun-jung, head of marketing at Viatris Korea.
Extensive drug-resistant TB is resistant to isoniazid and rifampin, which are representative TB drugs. The disease is also resistant to one or more quinolone-based drugs and at least one of three injectable second-line drugs -- amikacin, kanamycin, or capreomycin.
Among multi-drug-resistant TB, extensive drug-resistant TB is the hardest to treat, despite the smallest number of patients.