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FDA Approves ViiV Healthcare’s HIV-1 Treatment for Children
Other FDA approvals include Kite’s large B-cell lymphoma therapy, Yescarta, and Novartis’ drug for PIK3CA-Related Overgrowth Spectrum (PROS).
FDA recently approved ViiV Healthcare’s fixed-dose combination of abacavir, dolutegravir, and lamivudine to treat pediatric patients with HIV-1.
The agency also approved the company’s Triumeq tablet, lowering the minimum weight that a child with HIV-1 has to be to take this medication from 88 pounds to 55 pounds.
“We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option,” Deborah Waterhouse, CEO of ViiV Healthcare, said in the announcement.
“Developing pediatric formulations of anti-retroviral treatments is a priority for ViiV Healthcare because we want to ensure that no one living with HIV is left behind, and this approval means that we are one step closer to closing the gap between HIV treatment options available for adults and children,” Waterhouse continued.
Nearly 1.7 million children globally were living with HIV in 2020, and most AIDS-related deaths among this population occurred during the first five years of life. Therefore, the availability of age-appropriate treatment is vital in ensuring access to care for children.
In addition to its regulatory milestone, ViiV Healthcare also sent an application to the European Medicines Agency (EMA) for approval of its HIV-1 combination treatment and to extend the currently approved marketing authorization of Triumeq tablets to include a pediatric indication for children.
FDA Approves Kite’s Large B-Cell Lymphoma Therapy
FDA recently approved Kite’s Yescarta for adult patients with large B-cell lymphoma refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line therapy.
The agency based its approval on a Phase 3 study, which enrolled 359 patients in 77 centers globally to receive a single infusion of Yescarta or the current standard of care. The primary endpoint was event-free survival (EFS), the commencement of new lymphoma therapy, or death from any cause.
In the study, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment versus standard of care (16.3%).
Global regulatory authorities are currently reviewing Yescarta for additional indications.
“Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey,” Christi Shaw, CEO of Kite, said in the announcement.
“This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy,” Shaw continued.
FDA Approves Novartis’ Drug for PROS
FDA recently approved Novartis’ Vijoice to treat adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) or who require systemic therapy.
The agency based its approval on real-world evidence from the EPIK-P1 study, which showed that Vijoice reduced target lesion volume and improved PROS-related symptoms and manifestations.
Specifically, 27% of patients achieved a confirmed response to treatment, and no patients experienced disease progression at the time of primary analysis.
Vijoice is the first and only FDA-approved therapy for PROS, a variety of rare conditions characterized by overgrowths and blood vessel anomalies impacting about 14 people per million. PROS management can be challenging and require a multidisciplinary team.
“The approval of Vijoice marks a turning point for patients who, until now, have not had an approved therapy to specifically address their disease,” Victor Bulto, president of Novartis Innovative Medicines, said in the announcement.
“We are grateful to the physicians, patients, and families who participated in the EPIK-P1 trial. We are continuing to invest in studies to advance the scientific understanding of PROS conditions and to understand the full potential of Vijoice,” Bulto concluded.
