Business briefs: Aveo, Dynavax, Gilead, OPDP
Days after announcing it was pink-slipping 140 employees, Aveo revealed the details of the expected FDA rejection letter of its kidney cancer drug Tivozanib. The Complete Response Letter outlined the reason for the regulator's rejection, including what it called inconsistency in the progression-free survival and overall survival data. Aveo said the regulator found the data uninterpretable and inconclusive for making a risk/benefit analysis and recommended an additional study. The Wall Street Journal noted Monday that Aveo said last week it did not expect to pursue additional trials. The company has scheduled a conference call for tomorrow, which will address its restructuring and future plans.
FDA is not ready to give Dynavax's hepatitis B treatment Heplisav the go-ahead. The drug maker said in a statement Monday that FDA wants more test patients in the mix and it will be meeting with the agency to hammer out clinical trial details. Reuters notes that this is the second setback for the drug, and that the FDA sent the drug maker to get more information as recently as February.
Gilead's hepatitis C drug sofosbuvir has joined the FDA's pool of priority review drugs. The company said in a statement Friday that the FDA is now set to review the drug by December 8. The designation is granted based on several criteria, including “elimination or substantial reduction of a treatment-limiting drug reaction.” It doesn't shorten the clinical trial time period, but does limit the FDA's review window to six months. Oral sofosubuvir is being submitted to be used with ribavirin as all-oral treatment, as well as with ribavirin and pegylated interferon. Sofosbuvir, when combined with the J&J/Medivir drug simeprevir, was shown to clear the virus among patients, reported Bloomberg in March.
OPDP's summer hasn't been a quiet one. The FDA's bad ad cops hit Janssen with a May 22 Untitled Letter over its professional website for the ovarian cancer medication Doxil. The watchdog said the site was misleading and made unsubstantiated claims that associated levels of the CA-125 biomarker with results that cannot be proven with clinical experience. Its May 22 objections to Sigma Tau's sales aid for cancer med Oncaspar was lengthier, but came to the same point: the promotional material was misleading. In this instance, the regulator picked up the materials at the 52nd Annual Interscience Conference on Antimicrobial Agency and Chemotherapy, and said the literature includes unsubstantiated superiority clams, minimizes important risk information and omits material facts, among other violations.