Reata tumbles on launch delay for Friedreich's ataxia drug
10 May 2023
Phase 3Clinical ResultDrug ApprovalAccelerated Approval
Shares in Reata Pharmaceuticals dropped more than 14% on Wednesday after the company disclosed that the debut for its Friedreich's ataxia drug Skyclarys (omavaloxolone) would be delayed by a few months to sort out a manufacturing issue. The Nrf2 activator became the first drug indicated to treat the ultra-rare neuromuscular disease when the FDA approved it earlier this year for patients aged 16 years and older.
However, SVB Securities analyst Joseph Schwartz said in a report that the launch of Skyclarys has been delayed until August due to an impurity found in the manufacturing process, and that the FDA would now have to review supplemental materials from Reata. The drug's market entry had previously been targeted for May or June. In the meantime, roughly 500 patients have filled out start forms to request Skyclarys treatment.
"Considering there are an estimated 4500 addressable [Friedreich's ataxia] patients in the US, we believe this initial launch metric is encouraging," Schwartz said, but "we also note that it remains to be seen how many and how quickly these patients can get on commercial drug once Skyclarys becomes available."
CKD programme for bardoxolone scrapped
Meanwhile, Reata and its partner Kyowa Kirin also disclosed that they have discontinued development of bardoxolone in chronic kidney disease (CKD). The once-daily, oral activator of Nrf2 was being evaluated in the Phase III AYAME trial of over 1000 patients with diabetic kidney disease who received the drug or placebo for three to four years.
The study met its primary endpoint of time to onset of a ≥30% decrease in estimated glomerular filtration rate (eGFR) from baseline or end-stage renal disease (ESRD). It also achieved key secondary measures and showed no significant safety issues. However, Reata said there was "no separation in the occurrence of ESRD events" between the bardoxolone and placebo cohorts after three years of treatment. "Based on the results of AYAME and its potential regulatory impact, we…have decided to discontinue our bardoxolone CKD programmes," the company said.
SVB's Schwartz noted that the FDA had already declined to approve bardoxolone for CKD last year, "thus we think the Street had already written off this programme." For its part, Kyowa Kirin said it would also withdraw an application for the drug that it had filed in Japan in 2021 for Alport syndrome and that it plans to cease development for this indication as well.
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