Taiwan's PharmaEngine gets local FDA approval for Onivyde

Taiwanese biopharma company PharmaEngine (TWO: 4162) says that the Taiwan Food and Drug Administration (TFDA) has approved the product license of Onivyde (irinotecan liposome injection, nal-IRI).

Onivyde is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

In the USA it is being commercialized by Merrimack Pharmaceuticals (Nasdaq: MACK), which gained approval from the US Food and Drug Administration last year for Onivyde in combination with fluorouracil and leucovorin in advanced pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (The Pharma Letter October 23, 2015). The drug was originated by HERMES BioSciences, which Merrimack acquired.

There are two steps for the marketing approval of new drugs in Taiwan. The first step is to assess whether the chemistry, manufacturing and controls, preclinical and clinical data regarding the quality, safety and efficacy are sufficient to issue the regulatory approval letter; and the second step is to assess whether the product labeling and package insert are supported by the new drug application dossiers. Both steps are essential for product sales in the Taiwan market. Onivyde was granted the TFDA regulatory approval letter in October 2015. The approval of the commercial packaging materials and the GMP approval letters for two US manufacturing sites have been issued to allow the TFDA granting the product license of Onivyde. PharmaEngine's sales and marketing team is building the pharmacovigilance communication system to ensure patient safety after product launch. The company expects Onivyde to be available in Taiwan during the second quarter of this year.