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FDA denies Lilly’s appeal of its ruling necessitating additional Arxxant trial
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The U.S. Food and Drug Administration has denied Eli Lilly's appeal of the agency's ruling requiring an additional 3-year study of ruboxistaurin mesylate before it can be approved for treating diabetic retinopathy, the company announced at an investor conference Tuesday.
"While we are disappointed with the FDA's decision, we will not pursue the appeal further," said Steven Paul, president of Lilly Research Laboratories, at the conference.
In August of last year, the FDA, citing efficacy concerns, sent Lilly an "approvable" letter for Arxxant (ruboxistaurin mesylate) before ordering the additional trial in September. At that time, Lilly indicated its intent to appeal the decision, as such trials would delay commercialization by up to 5 years, the company said.
Now that the FDA has reiterated the need for an additional trial, Lilly is contemplating how to proceed with Arxxant, Lee Lange, a Lilly spokeswoman, told Ocular Surgery News in an interview. The company's options include conducting the requested study, seeking a development partner or terminating the drug outright, she said.
Lilly has also decided to withdraw Arxxant's marketing application from the European Medicines Agency (EMEA), where it was under review by the EMEA's Committee for Medicinal Products for Human Use (CHMP), according to a press release from the EMEA.
Although the CHMP did not explicitly request new studies, it had posed safety and efficacy questions to Lilly that "called for the generation of additional data ... within a timeframe [Lilly] could not meet," Ms. Lange said.
Lilly was seeking approval for Arxxant for treating nonproliferative diabetic retinopathy. Despite an uncertain future surrounding this original indication for the drug, Ms. Lange noted that Arxxant continues to be evaluated in two trials for diabetic macular edema.
"One ... is looking at the progression of macular edema within 300 µm of the center of the macular. And that's being done through photography," she said. Results from that trial are not expected until 2010, she noted.
"The other [trial] is looking at patients with more severe macular edema using [optical coherence tomography] as the endpoint," she said.