Everything isn’t going well with Gilead Sciences, Inc. (NASDAQ:GILD) at this moment. According to a report, the company has come under the radar of European Medicines Agency over the safety issues. EMA announced that it was reviewing Gilead Sciences’ cancer drug Zydelig after a series of adverse events, such as infections, deaths, etc. were reported.
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The authorities conducted three studies to evaluate Zydelig and other related cancer drugs and found that patients taking it were exposed to various risks. These studies included patients suffering from indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia. Based on the findings from these studies, the authorities will now check whether the results have any relation with Zydelig or not.
Meanwhile, all the patients who have either used this drug in the past or using it as of now should pay a close heed to any signs of infections. Authorities haven’t given any statement regarding a ban on Zydelig at this moment; hence, patients don’t need to stop their treatments if they don’t see any adverse effect.
EMA is carefully watching over this matter to ensure nothing goes unnoticed. It has already informed the officials to take into account certain measures, which need to be followed without any failure. The request to conduct the review of Zydelig was first made by the European Commission in connection with Article 20 review procedure. The Pharmacovigilance Risk Assessment Committee is trying its best to review this drug and find out if it needs to be banned.
After the review gets over, PRAC will submit its report to Committee for Medicinal Products for Human Use and seek final opinion to be considered by EC. Gilead Sciences is one of the premium stocks carrying ‘Buy’ recommendation from Zacks Investment. It will be great to see how it responds to this unscheduled review and proves its point.