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VOTE: 16-0 to recommend approval for tesamorelin - 'benefit outweighs risk'
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in answering the question "does the risk-benefit assessment.......support approval for the treatment of excess abdominal fat in HIV+ individuals with lipodystrophy".......despite the concern expressed about adverse effects - increased IGF-1 levels and increases in glucose abnormalities on tesamorelin and lack of data on whether the drug actually improves CVD outcomes.....panelists expressed concern about the suffering patients experience regarding body image with VAT which clearly is the reason they voted to recommend FDA approval.....panelists said the sponsor delivered on the primary outcome of the studies, improved VAT.....'equipoise between benefit and risk'.....need patient registry to track longterm effects.
Panel Discussion prior to the vote
There are only 2 on the panel who treat HIV and that is Princy Kumar and Vicki Cargill. Dr Kumar expressed that lipoatrophy is a major concern to patients and how they look perhaps more of a concern. Of course the panel is complete agreement that there is no data now to show CVD benefit by reducing VAT. A 2nd panelist expressed concern that lipoatrophy is a major concern for patients & self-image and of course teasmorelin only affects VAT. I'm surprised that no panelist has raised the point that there is no data on the prevalence of VAT with use of recently approved drugs and that much of the VAT occurred with ARTs not used much or at all any more, but of course there is a patient group remaining who have VAT. I think lipoatrophy is a much more prominent problem but some patients do suffer with extended bellies. I think a panel with more HIV treaters would improve the di scussions. A longterm post approval study could be a no-harm study rather than a benefit study.
During the panel discussion on the question about concern regarding the diabetes and glucose trends in the studies associated with tesamorelin. Most panelists expressed the opinion that the the trends towards glucose abnormalities are real but small in risk. However Princy Kumar said as an HIV treater she is concerned including because her patients take so many other drugs. Dr Kumar said she is concerned the patient populations in the phase 3 studies do not adequately reflect the numbers of African-Americans and Latinos with HIV who are at greater risk for the potential for glucose abnormalities, several panelists felt they could study this in phase 4 after approval. Most panelists felt glucose abnormalities could be managed. One panelist said the glucose abnormalities could in the long run cause a CVD risk.
Regarding cancer risk related to increased IGF-1 levels, the FDA is raising a concern that perhaps a phase 4 randomized trial to study whether tesamorelin improves CVD risk might not be able to be enrolled since patients who desire the drug may not want to be randomized and risk not getting the drug. I think Vicki Cargill is suggesting merely collecting this data without doing a randomized trial. It appears to me at this moment that the panel will recommend approval due to the benefits of improved VAT and the stigma associated with VAT. One panelist just expressed serious concern about high IGF-1 levels although several panelists expressed they were not concerned. This one panelist said even though the data is mixed regarding cancers & high IGF-1 levels he is concerned. The panelists are divided on whether a randomized study could be conducted. The panelists said they were moved with public commentary by patients. One panelists expressed she is more concerned with the ris ks associated with tesamorelin. One panelist just said he was concer ned with the high levels of IGF-1 and expressed concern. A panelist just raised the point that patients must stay on the drug to maintain benefit in the context of discussing potential longterm adverse affects. So now several panelists have now expressed concern about the toxicities and recommending approval. Here we go another panelist supporting approval, HIV+ patients should not have to wait for this drug. Conducting a study post-approval to see if teasmorelin improved CVD risk will take a long time and could be a collection of data by a registry rather than a randomized study. I think the majority of panelists do NOT think you can conduct a randomized study.
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