Fri, Feb 23, 2018 - Page 12 News List

PharmaEssentia upbeat following US FDA meeting

By Ted Chen  /  Staff reporter

Drug developer PharmaEssentia Corp (藥華醫藥) on Wednesday said that a meeting with US Food and Drug Administration (FDA) officials over the Lunar New Year holiday has brightened the outlook for its new blood cancer drug.

The company, said that the US regulator was highly receptive toward the drug, Ropeginterferon alfa-2b (Ropeg).

Its experts made the case that due to a lack of first-line treatments for polycythemia vera and other myeloproliferative neoplasms, Ropeg could fill an unmet medical need, it said.

Building good rapport with the US regulator would help its biologics license application, where approval would grant the company permission to introduce or deliver a biologic product into interstate commerce, the company said.

PharmaEssentia is aiming to submit a biologics license application this year and gain marketing approval by 2020, according to the Taipei-based company, which specializes in hematology.

The company took many months to assemble a delegation of key opinion leaders, former FDA officials and contract research organization representatives to attend the meeting with the regulator, it said.

Official meeting minutes by the FDA are expected in the next 30 days, the company said, adding that it would update the investing public with the relevant information.

More than 100,000 people in the US are seeking long-term first-line treatment options, the company said.

Shares in PharmaEssentia yesterday gained 0.3 percent to NT$168.5, down from a recent high of NT$173 on Feb. 9.

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