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The Spanish Agency for Medicines and Health Products (AEMPS), in its september bulletin recently published on its website, has included an extension of the indication in the medicine Symkevi (tezacaftor/ivacaftor), for the treatment of people with Cystic Fibrosis from 6 years of age (previously it was older than 12 years) homozygous for the F508del mutation or heterozygous for the F508del mutation with one of the following mutations in the Cystic Fibrosis Transmembrane Conductance Regulator gene (CFTR): P67L, R117C, L206W, R352Q, A455E, D579G, 711 + 3A → G, S945L, S977F, R1070W, D1152H, 2789 + 5G → A, 3272-26A → G and 3849 + 10kbC → T.
In this same bulletin, the AEMPS has also extended the indication of the drug Kalydeco (ivacaftor) in granulated format in sachets for babies from 4 months of age (previously it was from 6 months), with a R117H mutation in the CFTR gene or one of the following channel-opening mutations (class III) in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.
As the AEMPS explains in the bulletin, these are positive technical opinions from said agency that are prior to the authorization and placing on the market of the drug, which will happen in a few months. Once the drugs have been authorized, all the information on each of them (from the technical sheet and prospectus, to their prescription conditions, use and actual availability in the market) can be consulted on the AEMPS website, within the section CIMA: Centro de Información Online de Medicamentos de la AEMPS.
