Gilead Sciences, Inc. (NASDAQ:GILD) has announced that following the initiation of a review, concerning Zydelig, the company is going to halt a number of patient studies of the drug. Zydelig had initially been cleared for patient studies, but patients enrolled in the trial had started to exhibit development of infections, resulting in death.
The company had revealed that the signs were particularly common in patients undergoing late-stage testing. The patients were mostly suffering from lymphocytic leukemia and non-Hodgkin’s lymphoma. Consequently, the latter set of patients already had a damaged lymphatic-infection fighting system. Gilead Sciences has not yet disclosed the complete details of the unfortunate events and is still to update on the number of deaths.
A spokesman for the company, Nathan Kaiser, stated that the company would be reviewing all ongoing studies and will also collaborate with the regulatory bodies, regarding the matter. However, an earlier report on the matter had identified that the effects were observed in three particular studies, which were aimed at testing Zydelig in combination with other drugs. The reports had also identified that combinations of CLL treatments were not yet approved and the NHL patients had different characteristics, from the approved indications.
Currently, the regulatory bodies do not seem to be targeting Zydelig in particular, since the guidance issued by these bodies have stated that if the drug is found to be well tolerated in patients, it should not be stopped. Added to this, the guidance also states that the patients should be monitored for any signs of infections, after having the drug administered. Zydelig was responsible for generating $132 million, in sales, during 2015. Even though the drug has already been approved to be taken in combination with Rituxan, the EU regulatory would be reviewing the data from current studies to revaluate the initial decision.
Gilead Sciences, Inc. (NASDAQ:GILD) closed at a share price of $89.44, at the end of the March 15 trading session, after having a trade volume of 10.27 million and losing 1.13% of its share value.
