Thu, Mar 08, 2018 - Page 12 News List

US FDA approves TaiMed’s HIV drug, stock soars 10%

STRONG RESISTANCE:In a study of 40 people who no longer respond to other antiretroviral treatments, 43 percent achieved HIV RNA suppression, the FDA said

By Ted Chen  /  Staff reporter

TaiMed Biologics Inc (TMB, 中裕新藥) shares surged in Taipei yesterday after the company said its HIV/AIDS drug obtained a green light from the US Food and Drug Administration (FDA).

The stock shot up 10 percent to its daily limit of NT$234 shortly after opening, and remained at its peak throughout the session, outperforming the TAIEX, which fell 0.36 percent to 10,745.32 points.

The drug, marketed as Trogarzo (ibalizumab-uiyk), is a new antiretroviral for adults with HIV who have developed a resistance to other drugs, the company said.

Trogarzo is the first drug in a new class of antiretroviral medications that can significantly benefit a small percentage of patients who have run out of HIV treatment options, said Jeff Murray, deputy director of the Division of Antiviral Products at the FDA’s Center for Drug Evaluation.

Its introduction could improve the outcome for patients who are at high risk of potentially fatal HIV-related complications, he said in a statement.

In a study of 40 extremely treatment-experienced patients with multidrug resistance HIV-1, who continued to have a high virus load after being treated with 10 or more antiretrovirals, 43 percent achieved HIV RNA suppression, the FDA said.

Among the 292 patients who participated in Trogarzo studies, the most common adverse reactions were diarrhea, dizziness, nausea and rashes, with more severe side effects limited to severe rashes and immune reconstitution syndrome, the FDA said.

Trogarzo is administered intravenously once every 14 days in combination with other antiretrovirals, TaiMed said in a filing with the Taiwan Stock Exchange, adding that the wholesale price is US$118,000 per year.

The firm, which in May last year submitted a biologics license application to market the drug, said that the FDA had granted priority review, as well as orphan-drug and breakthrough-therapy designations, to help speed up the approval process.

TaiMed said it is in the process of designing a phase III clinical trial for an intramuscular injection formulation of Trogarzo.

In anticipation of the drug’s launch in the US, the company has increased its budget by NT$130 million (US$4.44 million) to build a new protein drug manufacturing plant, pushing total spending to NT$1 billion, a separate filing said.

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