Novartis might still be on the FDA outs
Having spent the whole summer parsing Novartis’ relationship with the FDA after a data falsification scandal, it’s a little tough not to reach for one’s tinfoil hat upon reading the headline “Novartis’ Zolgensma gene therapy study halted by FDA on animal safety concerns.”
The news is this: The FDA told Novartis to pause a trial meant to expand Zolgensma’s use after the company disclosed a safety issue from an animal study. That issue, related to inflammation, had never popped up in prior animal studies, the company said, and has never manifest itself in actual human beings.
Considering the fact that the FDA went out of its way to chastise Novartis over how it handled a wholly unrelated issue involving Zolgensma data, it’s fair to ask: Is the company getting maximum scrutiny by way of further punishment? According to SVB Leerink analyst Mani Foroohar, the issue is “likely reflective of FDA taking a more stringent attitude” toward Zolgensma. And, as other analysts noted, it could affect Novartis’ business: A lengthy delay to Zolgensma’s further development could allow a rival treatment from Roche to seize market share.
The news is this: The FDA told Novartis to pause a trial meant to expand Zolgensma’s use after the company disclosed a safety issue from an animal study. That issue, related to inflammation, had never popped up in prior animal studies, the company said, and has never manifest itself in actual human beings.
Considering the fact that the FDA went out of its way to chastise Novartis over how it handled a wholly unrelated issue involving Zolgensma data, it’s fair to ask: Is the company getting maximum scrutiny by way of further punishment? According to SVB Leerink analyst Mani Foroohar, the issue is “likely reflective of FDA taking a more stringent attitude” toward Zolgensma. And, as other analysts noted, it could affect Novartis’ business: A lengthy delay to Zolgensma’s further development could allow a rival treatment from Roche to seize market share.
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