Vertex's Cystic Fibrosis Drug Kalydeco Could See Speedy Review
This article was originally published in The Pink Sheet Daily
High unmet medical need, a genetically targeted patient population and the drug's biological rationale could combine for a faster-than-six-month approval for the novel, disease-modifying therapy.
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Kalydeco is expected to be a game-changer in cystic fibrosis, but its current label is applicable to only 4% of the patient population. Vertex, however, has an ongoing plan to expand Kalydeco’s label as both a monotherapy and in combination with other experimental CF agents.
Kalydeco, an oral CFTR potentiator, becomes the first approved drug to address the underlying cause of cystic fibrosis, rather than just treating the disease’s symptoms.
In One Day, Change At Biotechs: Leiden To Replace Emmens At Vertex And At Amgen, Bradway Will Become CEO
Board member Jeffrey Leiden, who oversaw the commercialization of Humira at Abbott, will succeed Matthew Emmens as Vertex CEO next February.