Protocols

FDA stiff-arms Aveo on tivo, again; Sunovion Parkinson’s drug rejected

Aveo Oncology was hit with a fresh setback on Thursday. Its 2013-rejected tivozanib is still not ready for a new marketing application, the company said, citing FDA feedback. The agency recommended that the drug developer not submit the application as preliminary overall survival data — reported last November — did not allay their concerns about the drug’s use in renal cell carcinoma outlined in their rejection letter in 2013. The new application will be made once mature OS results are available. “We are hopeful that the positive PFS (progression-free survival) outcome will translate into an improved hazard ratio when we evaluate a more mature interim OS outcome in the fourth quarter of 2019,” said Aveo chief Michael Bailey said in a statement. The company’s shares $AVEO cratered more than 55% in early trading.

Sunovion’s high hopes for its Parkinson’s drug — bought at a premium more than two years ago — is crashing down as it got slammed with a complete response letter from the FDA. Despite positive Phase III data reported last year, the FDA punted its NDA for the apomorphine sublingual film APL-130277 and requested more information and analyses, though the company said no new clinical studies are required. The drug is designed to treat OFF episodes of Parkinson’s, referring to the re-emergence or worsening of symptoms normally controlled by medications.

→ Madrid-based Sylentis has had to concede that its drug tivanisiran flopped in a Phase III study for dry eye disease, beaten out in a head-to-head with artificial tears. The drug failed to hit the primary endpoint on ocular pain and total corneal staining. Sylentis, though, spotlighted a secondary endpoint that did qualify for success: “reducing central corneal staining in patients with moderate to severe dry eye disease after one month of treatment with tivanisiran.” The biotech is a subsidiary of PharmaMar.

→ Jerusalem-based Anchiano Therapeutics has set terms for a $35 million IPO, according to Renaissance Capital. They plan to sell 2.4 million shares at $14.55 each. Insiders agreed to buy half of that.


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