Great roundup of a busy week. The Soleno patient death disclosure deserves more context than the headline might suggest - PWS patients have significantly elevated baseline cardiopulmonary risk due to the syndrome itself (obesity, hypoventilation, sleep apnea, etc), so a pulmonary embolus in this population is sadly not uncommon regardles of treatment. The treating physician's assessment that it was unrelated to VYKAT XR is critical, and the fact that FDA hasn't indicated any action suggests they agree with that assessment. This kind of transparent adverse event reporting is exactly what post-market surveillance is supposed to capture. On the Intercept Ocaliva withdrawal - that's a tough one given the lack of alternatives for PBC patients, but the benefit-risk calculus apparently didn't hold up in the confirmatory trial. Appreciate the detailed coverage.
Great roundup of a busy week. The Soleno patient death disclosure deserves more context than the headline might suggest - PWS patients have significantly elevated baseline cardiopulmonary risk due to the syndrome itself (obesity, hypoventilation, sleep apnea, etc), so a pulmonary embolus in this population is sadly not uncommon regardles of treatment. The treating physician's assessment that it was unrelated to VYKAT XR is critical, and the fact that FDA hasn't indicated any action suggests they agree with that assessment. This kind of transparent adverse event reporting is exactly what post-market surveillance is supposed to capture. On the Intercept Ocaliva withdrawal - that's a tough one given the lack of alternatives for PBC patients, but the benefit-risk calculus apparently didn't hold up in the confirmatory trial. Appreciate the detailed coverage.