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A new security signal that many feared could be hidden in Intercept's comprehensive Regnerate data did not materialize. However, what has become clearer is that Nash's hope, Intecept, Ocaliva, is only marginally effective, despite the company's efforts to present the results in the best possible light.
Most of the new discoveries on efficiency announced yesterday by Intercept are from per – protocol badysis. Gail Cawkwell, Intercept's chief of medical affairs, safety and pharmacovigilance, defended this exploratory badysis, pointing out that it had been predefined and suggesting that doctors might find it more useful.
"We have tried here to find a balance between what regulators would like to see and what is most relevant for doctors," she said. Advantage.
Not convinced
But the doctors who Advantage spoke to were not convinced by this argument. The Regenerate subgroup received biopsies at the beginning of the trial and at 18 months. He had to stay largely stuck to study the protocols, which, according to Dr. Ian Rowe, consultant in hepatology at the University of Leeds, UK, probably does not correspond to a patient's experience .
"There are many reasons why patients may not wish to undergo a second biopsy or could not tolerate the drug. You may have a better idea of the actual effectiveness, but you lose a lot of the important context, "he said. Advantage.
This is precisely why regulators require intent-to-treat badyzes. Ocaliva may well have a US breakthrough designation for Nash, but that does not mean the FDA will look at the data less thoroughly. And, although unmet needs may be an argument for approval, Ocaliva's security profile is hardly clean.
Dr. Rowe also has concerns about this, particularly in patients with pre-symptomatic stages of fibrosis in which Regenerate has been administered and for whom Intercept is likely to seek approval.
"Liver events are quite rare in patients with stage 2 or stage 3 fibrosis. [of Ocaliva] is already quite small; if you then make the patients symptomatic, they will simply not take the medicine, "he said. "At the beginning of fibrosis, I do not consider it a good treatment."
Dr. Rowe also pointed out that in any event, about 20% of early-stage patients spontaneously improve, which must also be recalled when Intercept speaks of a response rate to the 30% fibrosis. The real need for reversal of fibrosis is in advanced patients, the population studied in the Intercept reverse study – particularly patients with compensated cirrhosis.
The results of Reverse are expected later this year and will provide important information on the actual effectiveness of Ocaliva, says Dr. Rowe.
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