Novartis gives up on Xiidra's EU approval, endangering payoff from $3.4B Takeda buyout

Created on:2020-06-27 09:00

 

Novartis last year bought Shire’s dry eye drug Xiidra from Takeda to beef up its ophthalmic offerings and reap blockbuster sales along the way. But now, the $3 billion-plus buy doesn't look so appealing.

Novartis has voluntarily withdrawn an application for Xiidra in Europe after regulators there raised “major objections” that “cannot be resolved within the available time frame,” according to a letter from the company posted Friday by the European Medicines Agency.

That doesn't necessarily mean Novartis has entirely given up on Xiidra in Europe; in a statement, the company said it is committed to evaluate next steps. “We will determine the best route forward following further internal assessment,” it said.

But it does chart a more difficult path for Xiidra growth. When Novartis bought the drug for $3.4 billion up front, it boasted of Xiidra’s $400 million in 2018 sales and its “blockbuster potential” down the road. Without an EU nod, the Swiss drugmaker will have to try even harder to make the investment worthwhile.

Before Novartis admitted defeat, drug reviewers at the European agency’s Committee for Medicinal Products for Human Use had expressed doubts about Xiidra’s clinical profile.

Specifically, the agency concluded that Xiidra hadn't proven effective across different symptoms of dry eye disease. “Although some effect was seen in the reduction of eye dryness, the improvement was not considered clinically significant,” the EMA said.

Xiidra had been aiming for an approval in serious dry eye patients who couldn’t find relief with artificial tears, but the EMA worried that pinpointing those patients would be difficult. What’s more, the agency took issue with the fact that Xiidra was pitted against placebo in its clinical trial, rather than an active comparator. The lack of long-term data for a chronic disease as eye dryness also played a part.

“Because effectiveness was not proven, the benefits of Xiidra did not outweigh its risks,” the EMA said.

 

 

 

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