Shots: The EMA’s CHMP has adopted a positive opinion for the label extension of Kaftrio in combination with ivacaftor to treat CF in patients aged 6 to11 yrs. who have […]readmore
Shots: The approval is based on a P-III study evaluating the safety, PK & efficacy of Trikafta in 66 children aged 6-11yrs. old with CF with either two copies of […]readmore
Shots: The interim data from 18 patients out of 20 in P-II trial evaluating the safety, tolerability, and efficacy of MS1819 (700/1200/2240 mg, qd, for 15 days/dosing level) + PERT […]readmore
Shots: In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control group was observed Bronchitol is […]readmore
Shots: The EC has granted MAA to Kaftrio (ivacaftor/tezacaftor/lumacaftor) + ivacaftor (150mg) to treat people with CF aged ≥12yrs. with one F508del mutation and one minimal function mutation (F/MF), or […]readmore
Shots: The EC’s approval is based on P-III ARRIVAL open-label safety study assessing Kalydeco in children with CF aged < 24mos. with CFTR gating mutation, demonstrated similar safety profile as […]readmore
Shots: The two P-III studies involve assessing of Trikafta in 403 & 107 patients aged ≥12yrs. with CF with one F508del mutation and one minimal function mutation (F/MF) in the […]readmore
Shots: The approval is based on two global P-III studies assessing Trikafta in 403 & 107 patients with CF aged ≥12yrs. with at least one F508del mutation and one minimal […]readmore
Shots: The approval is based on P-III ARRIVAL study results assessing Kalydeco (ivacaftor) in 11 children with CF aged 6mos. to <12 mos. with 1/10 mutations in the CFTR gene […]readmore
Shots: The approval is based on P-III EVOLVE & EXPAND studies result assessing Symdeko vs PBO in 750 patients with CF having two copies of the F508del mutation or with […]readmore
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