Positive opinions from US FDA and EMA for ViiV Healthcare’s Dovato®: April’s industry headlines


Take a look at this month’s industry headlines including news from ViiV Healthcare on long-acting and single dose formulations, sales for Eli Lilly and the possible development of a plague vaccine. 

ViiV Healthcare announces Juluca® maintains HIV viral suppression at 148 weeks

148-week results from the SWORD studies have demonstrated the long-term efficacy and tolerability of Julaca, a two-drug regimen, for the treatment of virologically suppressed adults with HIV. The 3-year results, presented at the 25th Annual Conference of the British HIV Association (25 April, Bournemouth, UK) demonstrated that 84% of participants who switched to Julaca (dolutegravir/rilpivirine) from a three- or four- drug regimen maintained viral suppression. 

Discover earlier results from the SWORD study >

SWORD investigator Chloe Orkin (Queen Mary University, London, UK), commented: “With the SWORD data we now have 3year data showing the excellent effectiveness and tolerability of Juluca, the first approved dolutegravir-based two-drug regimen. Importantly, the improvements in bone markers seen at earlier timepoints in the study are maintained over 3 years. 

“Combined with the potential benefits of lowering the number of antiretroviral agents patients take, these data support the strategy of switching virologically-suppressed, stable patients to the two-drug regimen of dolutegravir and rilpivirine.” 

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US FDA and EMA approves ViiV Healthcare’s Dovato®  

US FDA approves ViiV Healthcare’s (Brentford, UK) Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults. The approval was based on the pivotal GEMINI trials in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, traditional, three-drug regimen through 48 weeks, with no cases of resistance. 

Deborah Waterhouse, CEO, ViiV Healthcare, said: “Building on our innovative portfolio of medicines, Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine. With Dovato, the first complete, single-tablet, two-drug regimen for treatment-naïve adults, ViiV Healthcare is delivering what patients are requesting—a chance to treat their HIV-1 infection with as few drugs as possible, marking a significant step in HIV treatment.” 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has also issued a Positive Opinion recommending marketing authorization for Dovato for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.  

A CHMP Opinion is one of the final steps before a marketing authorization decision is made by the European Commission, with a final decision anticipated within the coming months. 

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Summit Therapeutics presents data for new antibiotic at ECCMID 

Summit Therapeutics (Abingdon, UK) have presented in vivo proof of concept data for the DDS-04 series of new-mechanism antibiotics targeting Enterobacteriaceae at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID; 11-16 April, Amsterdam, the Netherlands). 

The DDS-04 series acts via LolCDE, a novel bacterial target. The data demonstrated that a DDS-04 compound was effective in curing an animal model of urinary tract infection, with therapeutic concentrations of the drug also observed in other sites in the animal.  

“The DDS-04 series aligns with our antibiotic strategy. There is a clear opportunity to improve patient outcomes and a need for new mechanisms to deliver these improved outcomes and also to help address the spread of antimicrobial resistance,” commented Glyn Edwards, Chief Executive Officer of Summit. “We look forward to gathering further data to support the selection of a preclinical candidate from the DDS-04 series.” 

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Eli Lilly sell rights to two antibiotics 

Eli Lilly (IN, USA) has announced an agreement to sell the rights for two antibiotics, Ceclor (cefaclor) and Vancocin (vancomycin) in China. Julio Gay-Ger, general manager of Lilly China, said the transaction “will enable Lilly China to better focus our resources on the exciting new therapies that we are launching in our core therapeutic areas.” 

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Enesi and Oxford Vaccine Group to create first plague vaccine 

Enesi Pharma (Milton Keynes, UK) and the Oxford Vaccine Group (OVG; UK) have signed a collaborative agreement hoping to combine an innovative delivery method with a potent immunogen to create a plague vaccine. 

The hope is to formulate OVG’s chimpanzee adenovirus vector, termed ChAdOx, into Enesi’s ImplaVax technology, which uses a needle-free device to implant a solid dose of drug under the skin, making it potentially easy to stockpile. 

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ViiV Healthcare submits New Drug Application to FDA for long-acting HIV treatment cabotegravir and rilpivirine 

ViiV Healthcare has submitted a New Drug Application to the US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for HIV treatment. The submission is based on the pivotal Phase III studies ATLAS and FLAIR, which included over 1100 patients across 16 countries, demonstrating the injectable regimen was as effective as the standard-of-care throughout the 48-week study period.  

Find out more about the 48-week results from the ATLAS study >

Deborah Waterhouse, CEO of ViiV Healthcare, commented: “The long-acting, once-monthly, injectable regimen of cabotegravir and rilpivirine has the potential to give people living with HIV one month between doses with similar safety and efficacy as today’s standard of care – an oral three-drug regimen that has to be taken every day. ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US this novel option.” 

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Missed last month’s headlines? Catch up now!

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