Vertex Eyes Triple Glory After Hat Trick of CF Approvals
Symdeko, which will have a wholesale price of $292,000 per year, has got the green light in the US, adding to Vertex' already-approved cystic fibrosis treatments Kalydeco and Orkambi. Now, focus will shift onto its role in potential triple combinations for the disease.
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The number of US drug approvals in 2018 was striking, but most of the novel products launched last year are for rare diseases or niche cancers, meaning commercial success may be in the eye of the beholder.
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.
Vertex duplicated promising efficacy observed in Phase II for its cystic fibrosis triple combo that includes VX-659, but wants to see data expected in early 2019 for a triplet containing VX-445 before filing for approvals.