Teva Pharmaceutical Industries Ltd (NYSE:TEVA) recently suffered a blow when the FDA rejected a marketing application for its drug candidate targeting Huntington’s disease. Does that mean the end of the road for Teva’s deutetrabenazine? In its letter to Teva, FDA outlined the reason for refusing to approve deutetrabenazine and as it turns out, it is a problem that Teva could address without returning to the clinic for further studies.
According to FDA, it can only green light the commercialization of deutetrabenazine after it sees more information on the effects of the drug on patients who take it. Specifically, the FDA is demanding more data regarding the blood levels of certain metabolites when deutetrabenazine is consumed.
Teva will have to look into that matter as requested by the regulator if it wants the drug approved. Given the high premium the company’s investors are putting on the revenue potential of deutetrabenazine, Teva cannot afford to bring the curtains down on the drug. However, the company seemed to downplay the issue raised by the FDA saying that metabolites impacted as a result of using deutetrabenazine are not novel. The company went on to say that the same metabolites impact noted with deutetrabenazine can been seen in drugs already approved by FDA.
No request for additional clinical data
The FDA’s latest demand regarding deutetrabenazine appears easy for Teva to navigate because the company will not have to return to the clinic to conduct additional trials of the drug. That explains why the company expects to respond to the regulator’s request next quarter after it examines the effects of the treatment on certain metabolites.
Deutetrabenazine is designed to help manage a devastating physical symptom of Huntington’s disease. The symptom specifically targeted by the drug is called chorea and it is characterized by involuntary motion in people afflicted by Huntington’s.
Analysts believe that Teva Pharmaceutical’s deutetrabenazine will eventually secure regulatory clearance to enter the market. However, its expected revenue benefits will likely be delayed because it will likely be launched later than previously anticipated.