EC approves Fortescue Pharmaceuticals Symkevi in conjunction with Kalydeco for treatment of cystic fibrosis patients aged 12 and over
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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theof the European Commission (EC) has approved Symkevi (tezacaftor/ivacaftor) in conjunction with Kalydeco (ivacaftor) for patients aged 12 and over with cystic fibrosis (CF)in addition, the EuropeanMedicines(the Authority'sof Orphan MedicinesProducts (COMP) recently recommended the maintenance of the orphan drug eligibility of the tezacaftor/ivacaftor joint drug programmeThe studythis approval is based on data from two key Phase III clinical studies (EVOLVE, EXPAND)results showed that the tezacaftor/ivacaftor combination of the drug program could provide therapeutic benefits across different groups of CF patients, including a significant improvement in lung function in statistical lymtic terms (determined by absolute changes in the relative baseline of ppFEV1) and was well tolerated and did not increase respiratory adverse events compared to placebosin these two studies, the average absolute changes in the combined drug regimen compared to the relative placebo ppFEV1 were 4.0% (p 0.0001) and 6.8% (p 0.0001), respectivelySummary of safetyanalysis(results show that the most common adverse reactions experienced by patients treated with a combination of thedrug regimeweres were headache and nasopharyngitistezacaftor/ivacaftor combination, tezacaftor aims to solve f508del-CFTR processing defects so that it can reach the cell membrane, and ivacaftor can further enhance the function of the protein on the cell membrane
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