Novartis has decided to withdraw its marketing application seeking approval of dry eye drug Xiidra (lifitegrast) in Europe. The decision comes after the European Medicines Agency (EMA) said the drug’s benefits did not outweigh its risks.
Novartis pulled the application on June 18 after the EMA considered that the effectiveness of Xiidra was not demonstrated across different symptoms of dry eye disease. The EMA stated that “Although some effect was seen in the reduction of eye dryness, the improvement was not considered clinically significant.” The EMA also noted that there were no data on the effect of long-term treatment with Xiidra despite eye dryness being a chronic disease.
In a statement to Eyewire News, Novartis stated that it decided to discontinue the application as the objections raised “could not be resolved within the available timeframe.” Novartis said it will evaluate the next steps and determine the best route forward following further internal assessment.
Novartis’ application was backed by results from two main studies involving a total of 1,429 adults with dry-eye disease that compared Xiidra to a vehicle treatment, with the main efficacy measures being reduction in damage to the cornea and severity of symptoms, including eye dryness and discomfort.
Novartis purchased the rights to Xiidra from Takeda for $3.4 billion upfront in in 2019, part of a deal potentially worth as much as $5.3 billion. Xiidra is approved in the US, Canada, Australia and six other countries. The decision to withdraw the application of Xiidra in the EU does not affect its regulatory status in these markets.
Novartis said it is currently investigating a number of front of eye products: UNR844 for presbyopia, ECF843 for dry eye disease, and SAF312 for chronic ocular surface pain. The company is also pursuing a novel digital therapy for the treatment of amblyopia.
According to the EMA,
The EMA said it had put some questions to Novartis regarding its filing, but there were still some “unresolved issues” following the company’s responses. However, based on a review of the data, the agency stated that its provisional opinion was that Xiidra could not have been authorised for the dry-eye indication Novartis was seeking as the drug’s benefits did not outweigh its risks.
The EMA said the effectiveness of Xiidra had not been demonstrated across different symptoms of dry eye disease. Specifically, the agency noted that while some effect was seen with Xiidra in terms of reducing eye dryness, the benefit was not clinically significant. Moreover, as Xiidra was intended for use in patients with more severe disease in whom artificial tears were insufficient, the EMA argued that studies used to back Novartis’ filing had not used artificial tears in an optimal way. It added that there were also no data assessing the long-term effects of using Xiidra, despite the fact that eye dryness is a chronic condition.
Unable to address concerns in timeframe
In its withdrawal letter, Novartis said it has “decided to discontinue this application since the major objections raised cannot be resolved within the available time frame.” The company indicated that there are currently no ongoing clinical trials with Xiidra, but that it will continue to support the EU-approved compassionate-use programme for the drug. It also left open the possibility of making further submissions in the future for dry-eye or other indications.
Xiidra gained FDA approval in 2016 to treat the signs and symptoms of dry-eye disease in adults, with the drug marketed by Shire until its $62-billion takeover by Takeda early last year.