J&J bids for EU OK on Legend CAR-T; FDA extends review period for Ardelyx's phosphorus control drug
J&J may be on its way to its first cell therapy approval on two continents.
The big pharma announced on Friday that they had applied for the EU to approve the CAR-T therapy for multiple myeloma they are co-developing with Nanjing-based Legend Biotech. The therapy is now sitting before regulators in both Europe and the US, where J&J started a rolling submission in January.
The applications put the CAR-T on track to complete a meteoric rise to market next year and compete with a rival therapy from bluebird bio and Bristol Myers Squibb that goes after the same cancer receptor, BCMA, but has shown significantly worse efficacy in clinical trials.
J&J paid Legend $350 million cash to partner on the therapy four years ago, just 6 months after the previously unknown biotech dropped a 100% response rate and 94% remission at ASCO. Although bluebird dismissed the numbers at the time, arguing Legend had an easier patient population, but response rate has stayed high even as clinical trials have expanded. — Jason Mast
FDA extends review period for Ardelyx’s CKD drug
After “constructive discussions” with the FDA about additional analyses for its phosphorus control drug for CKD, Ardelyx announced Friday that the review data for its tenapanor has been extended by three months.
The new date has been set for July 29, giving Ardelyx time to provide info to the FDA on how the drug’s mechanism of action works. The biotech tied the delay to the pandemic, saying that the FDA hadn’t had enough time to review its updated data.
“While disappointed in the delay, we understand the impact that the COVID-19 pandemic has had on the operations of the agency,” Ardelyx CEO Mike Raab said in a statement. “We appreciate the constructive labeling discussions with the agency over the past month and believe that the additional analyses submitted in response to recent dialogue with the agency reinforce the extensive clinical evidence we generated on tenapanor.” — Kyle Blankenship