PharmaEssentia's Ropeginterferon alfa-2b (referred to as Ropeg, or P1101) continues to expand its footprint in the Americas. Following its application for Brazilian PV drug certification on March 28th, the company has recently submitted an application for PV drug certification in Colombia. This move has gained approval from the Colombian Food and Drug Administration (INVIMA) under the "Named Patient Program" (NPP), allowing patients with urgent medical needs to import and use the drug under this special program.
PharmaEssentia stated that its supply chain team has been collaborating closely with its authorized partner in Latin America, Pint-Pharma GmbH, to arrange shipment arrangements in compliance with relevant regulations. The team aims to provide the drug to patients as quickly as possible, ensuring that more patients can benefit from it.
The approval for Ropeg to be imported under the special program in Colombia lays a solid foundation for its commercialization and sales in Latin America, marking a smooth start towards establishing its leading position in the treatment of Myeloproliferative Neoplasms (MPN).
In the Canadian market, clinical trials for Ropeg in the treatment of Essential Thrombocythemia (ET) and Polycythemia Vera (PV) are currently underway. Local doctors and patients have reported highly positive experiences. PharmaEssentia pointed out that drug prices in Canada are generally much lower than in the United States. With the company's efforts, Ropeg is expected to soon overcome pricing barriers in Canada. Negotiations with local distributors are ongoing, with the aim of introducing Ropeg into Canada as soon as possible, benefiting more PV patients in North America and further expanding Ropeg's presence in the North American market.
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