Apellis has had its European ambitions dashed once again after regulators reaffirmed their decision to not recommend the company’s treatment for geographic atrophy due to age-associated blindness.
The EMA’s Committee for Medicinal Products for Human Use concluded that Syfovre’s ability to slow the growth of geographic atrophy lesions has not translated to a clinical benefit. Moreover, the committee said that new treatments should show a benefit to patients’ daily function “and this was not demonstrated in the studies.” They also felt that the required injections into the eye carried significant safety risks.
“Although the Agency recognises the unmet medical need for effective treatment for people with geographic atrophy caused by AMD, its opinion remained that the magnitude of Syfovre’s effectiveness did not outweigh the potential risk,” the regulators wrote. The decision was included in the committee’s latest meeting highlights released Friday.
Cedric FrancoisApellis CEO Cedric Francois and German study investigator Frank Holz both lamented the decision in a statement. Analysts at Mizuho said the company has restructured its European team as a result, with about 40 employees let go. A spokesperson for Apellis did not immediately respond to a request for comment.
TD Cowen called the stance “expected, but disappointing nonetheless.” They don’t expect the decision to impact uptake or prescribing in the US and maintain that the drug could exceed $2 billion in global sales in 2028, with the vast majority of the revenue coming from the US. They still think that Syfovre will snag approval in some ex-US locations, with filings still active in the UK, Canada and Switzerland, among others.
The company’s shares were down about 9% after the market opened on Friday.
Roche pulls Tecentriq filling
The Swiss pharma pulled the application for Tecentriq in combination with Avastin to treat patients with a common form of liver cancer who are at high risk of recurrence post-surgery. The company said in a letter that the decision was based on updated study results from the Phase 3 IMbrave050 trial that were “not sufficient to support an extension” in the indication.
The results have no impact on other studies testing Tecentriq as a monotherapy or as a combination with Avastin. The withdrawal also does not impact the combo’s existing approval to treat patients with more advanced forms of hepatocellular carcinoma or who can’t get surgery.
CHMP’s provisional opinion was that Tecentriq could not be approved in the new indication based on the data and had prepared questions for the company. Regulators were also skittish about the safety profile and felt that more data were needed on deaths in the trial and whether or not they were related to the treatment.
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