US Approval For ViiV’s ‘Last Resort’ HIV Drug Rukobia
Attachment Inhibitor Aimed At Heavily Pre-Treated Patients
The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.
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A potent HIV maturation inhibitor has entered Phase IIb at ViiV Healthcare, in combination studies with other antiretrovirals, as the latest potential first-in-class agent to move along the company’s pipeline.
A first-in-class capsid inhibitor for HIV, lenacapavir has produced strong efficacy data for viral load reduction in treatment-experienced patients. The data measure up well against Viiv’s Rukobia, analyst says.
ViiV Healthcare will not be able to launch its cabotegravir and rilpivirine long-acting HIV treatment in January after receiving an FDA Complete Response Letter.