Alnylam, a pioneer in the gene-slicing medical segment has made the shocking announcement that it will be halting the testing phase and any future production of their would-be miracle revusiran based meds, thus causing a 10 percent plunge in the company’s stocks and serious public setbacks.
The decision was made after stage tests have shown that the revusiran based meds tip the mortality scale in the wrong direction. As the risk-benefit profile indicates a serious imbalance, the company has decided to put a stop to dosings. In an unexpected and almost improbable case, results have shown that the revusiran leg of the studies has determined more deaths than the placebo medication testing.
The company CEO, John Maraganore has declared that after the baffling test results were received, all dosing with revusiran based medications was stopped and that the company is carefully monitoring its patients in order to ensure their safety.
According to the same Maraganore, the cause of these negative effects is as yet unknown and studies will be made in order to determine their cause. The company’s decision to discontinue studies and to put a stop to on-going trials has already been transmitted to all concerned investigators, collaborators, and regulatory authorities
The drug, which was expected to become the company’s blockbuster by the next decade, was used in the Phase III part of their neuropathy trial tests. As in late summer a number of three adverse reaction events were deemed to be possibly related to the use of revusiran, a board was commissioned to study the data from an unblinded basis.
Although the board found no conclusive evidence that would point to the drug as the most probable cause for the neuropathy’s progression, it nonetheless advised the company to discontinue its Phase III dosing due to the absence of any foreseeable advantages. As observed by the commission, the revusiran arm of testing not only failed to produce satisfactory results it has also shown a mortality imbalance.
A clear cause for these results was not yet found and due to the advanced age of the patient population and their increased number of concomitant medication, a deeper research will have to be performed in order to understand the revusiran data.
Still, after a closer look into the company’s safety data, Alnylan shared their conclusions that showed that no drug-related neuropathy signals were detected in any of the 800 treated subjects with a 34 month drug exposure and that the revusiran based meds problem, although a setback, will not be allowed to affect other ongoing studies.
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