Barcelona, May 13th – We are pleased to announce positive results from two pivotal bioequivalence studies evaluating Ivacaftor 150 mg Film-coated tablets against the reference product Kalydeco® (ivacaftor) under both Fasting and Fed conditions indicated for certain forms of cystic fibrosis.
According to Fabiana d’Aniello, Medichem’s Chief Scientific Officer, “These positive results represent an important milestone in the development program and support the continued advancement of Ivacaftor 150 mg Film-coated tablets as a high-quality therapeutic alternative for patients living with cystic fibrosis. This outcome also reflects Medichem’s strong development capabilities in complex generics, as well as its commitment to quality and operational excellence across all stages of pharmaceutical development and manufacturing.”
The studies were completed without significant protocol deviations affecting the overall conduct of the trials.
This achievement further reinforces Medichem’s capabilities in the development of complex pharmaceutical products and its commitment to delivering reliable, high-quality medicines supported by strong scientific, analytical, manufacturing, and regulatory expertise.
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About Ivacaftor
Ivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator designed to improve the function of the defective CFTR protein in patients with cystic fibrosis. By increasing the probability that the CFTR channel remains open, Ivacaftor enhances chloride ion transport across epithelial cell membranes, helping to improve hydration and clearance of mucus in multiple organs, particularly the lungs.
Ivacaftor is indicated for the treatment of specific mutations in the CFTR gene and has contributed to a significant shift in the management of cystic fibrosis by targeting the underlying protein dysfunction rather than only addressing symptoms. Its development represents an important advancement in precision medicine for patients with this rare genetic disease.
