Nelson Vergel
Founder, ExcelMale.com
As of September 17, 2014 (last FDA meeting to review requirements for testosterone studies and products), approval of testosterone replacement products has become a lot more difficult in the United States. This was fueled by two flawed studies that linked testosterone to cardiovascular risks and also by the abuse in testosterone product marketing. These are the two last companies that have been affected since that day.
Published on FierceBiotech (http://www.fiercebiotech.com)
Repros plummets as the FDA deals a blow to its low-T hopes
October 17, 2014 | By Damian Garde
After years of clinical and regulatory setbacks, Repros Therapeutics ($RPRX) was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for that meeting and indefinitely delaying Repros' plans.
Last month, Repros heralded that it had nailed down a Type B pre-NDA meeting, in which FDA reviewers would guide on how to go about submitting Androxal, a small-molecule treatment for low testosterone. Now, however, the agency no longer considers Repros' clinical data to be sufficient, and it has changed the calendar entry to a Type C guidance meeting. What that means for Androxal's long-term regulatory fate is unclear, but it almost certainly nixes Repros' goal of an end-of-the-year filing.
The biotech's shares tanked more than 40% on the news, the latest setback for a company that has struggled for years to get its low-T drug on the market.
Repros said it doesn't know what led the FDA to change its mind on Androxal, but the agency's issue with the company's Phase III data are already well-established. Last year, Repros had to put off a planned mid-2014 filing for the drug when the agency called into question the company's chosen patient populations and endpoints in two late-stage trials. The parties eventually came to terms, with Repros amending its analysis, and the biotech believed it was finally on the path to Androxal's approval.
Things were looking up for Repros before its latest regulatory setback, as the company announced in August that Androxal beat out AbbVie's ($ABBV) top-selling AndroGel in boosting testosterone, one of two planned head-to-head studies. Furthermore, the company believed the FDA's recent scrutiny of testosterone-replacement therapies left Androxal, which isn't a form of testosterone, unscathed.
Repros hasn't given up hope for the oft-delayed treatment, pointing out that data packet under FDA consideration does not include results from a one-year safety or a drug-drug interaction trial, information the company believes may be significant to the agency's review.
This was the first company that was told they need more data after the Sept 17, 2014 meeting where the FDA said they will be more strict with testosterone companies seeking product approval:
September 19, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
The U.S. Food and Drug Administration has shot down private company Clarus Therapeutics' oral testosterone drug Rextoro (oral testosterone undecanoate), saying Thursday that the company had not done enough to allay fears that testosterone therapy can lead to elevated risks of heart attack and other cardiovascular events.
The FDA's urologic and drug safety committees voted 18-3 with one abstention to deny Clarus's application for approval for the drug, saying the company had provided incomplete data from the drug's two Phase III trials. The FDA's final decision on Rextoro's fate is due by Nov. 3. - See more at: http://www.biospace.com/news_story.aspx?StoryID=347110&full=1#sthash.4TXkVg6Y.dpuf
Published on FierceBiotech (http://www.fiercebiotech.com)
Repros plummets as the FDA deals a blow to its low-T hopes
October 17, 2014 | By Damian Garde
After years of clinical and regulatory setbacks, Repros Therapeutics ($RPRX) was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for that meeting and indefinitely delaying Repros' plans.
Last month, Repros heralded that it had nailed down a Type B pre-NDA meeting, in which FDA reviewers would guide on how to go about submitting Androxal, a small-molecule treatment for low testosterone. Now, however, the agency no longer considers Repros' clinical data to be sufficient, and it has changed the calendar entry to a Type C guidance meeting. What that means for Androxal's long-term regulatory fate is unclear, but it almost certainly nixes Repros' goal of an end-of-the-year filing.
The biotech's shares tanked more than 40% on the news, the latest setback for a company that has struggled for years to get its low-T drug on the market.
Repros said it doesn't know what led the FDA to change its mind on Androxal, but the agency's issue with the company's Phase III data are already well-established. Last year, Repros had to put off a planned mid-2014 filing for the drug when the agency called into question the company's chosen patient populations and endpoints in two late-stage trials. The parties eventually came to terms, with Repros amending its analysis, and the biotech believed it was finally on the path to Androxal's approval.
Things were looking up for Repros before its latest regulatory setback, as the company announced in August that Androxal beat out AbbVie's ($ABBV) top-selling AndroGel in boosting testosterone, one of two planned head-to-head studies. Furthermore, the company believed the FDA's recent scrutiny of testosterone-replacement therapies left Androxal, which isn't a form of testosterone, unscathed.
Repros hasn't given up hope for the oft-delayed treatment, pointing out that data packet under FDA consideration does not include results from a one-year safety or a drug-drug interaction trial, information the company believes may be significant to the agency's review.
This was the first company that was told they need more data after the Sept 17, 2014 meeting where the FDA said they will be more strict with testosterone companies seeking product approval:
September 19, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
The U.S. Food and Drug Administration has shot down private company Clarus Therapeutics' oral testosterone drug Rextoro (oral testosterone undecanoate), saying Thursday that the company had not done enough to allay fears that testosterone therapy can lead to elevated risks of heart attack and other cardiovascular events.
The FDA's urologic and drug safety committees voted 18-3 with one abstention to deny Clarus's application for approval for the drug, saying the company had provided incomplete data from the drug's two Phase III trials. The FDA's final decision on Rextoro's fate is due by Nov. 3. - See more at: http://www.biospace.com/news_story.aspx?StoryID=347110&full=1#sthash.4TXkVg6Y.dpuf
