2024-04-18 19:28:44
In order to guarantee an agile and transparent regulatory process that allows the Federal Commission for the Protection against Health Risks (Cofepris) approve the application for recognition of Trikafta as an orphan drug for the treatment of cystic fibrosis.
According to the Cofepris, in a technical session with representatives of Vertex Pharmaceutical They reported the progress in the necessary procedures and the public servants resolved doubts regarding the formation of the technical file, the distributor’s documentation and the review period of the recognition request, among other topics.
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“Likewise, in line with the priority of Cofepris “To promote the identification of innovative therapies at a global level, it was agreed to assign a specialized team of officials for the detailed analysis of the documentation, once received, in order to guarantee an agile and transparent regulatory process.”
Trikafta is a new medicine that has been previously authorized by counterpart agencies such as the United States Food and Drug Administration (FDA, for its acronym in English) and the European Medicines Agency (EMA, for its acronym in English). Cystic fibrosis is an inherited genetic disorder characterized by lung congestion, infections, and nutrient malabsorption.
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In Mexico, On average, 300 people are born with cystic fibrosis each year. And, according to the General law of healthOrphan drugs are those intended for the prevention, diagnosis or treatment of rare diseases, with a prevalence of no more than five people per 10 thousand inhabitants.
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2024-04-18 19:28:44