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GSK PLC on Thursday said its subsidiary ViiV Healthcare has received marketing authorisation in China for its cabotegravir treatment, marketed as Vocabria.
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Long-acting HIV-1 treatment may remove need for daily therapy ViiV Healthcare has received Marketing Authorisation for the first complete long-acting injectable HIV treatment in Europe. Marketing Authorisation has been granted by the European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used with Janssen’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets). The long-acting injectable regimen was preferred by the majority of clinical trial patients who tried the treatment over their previous daily oral therapy. ViiV Healthcare, owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, announced the authorisation of the new treatment in the European Union (EU), for the treatment of HIV-1 infection in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the EU, for the treatment of HIV ....
GSK delivers FY 2020 reported sales of £34 billion, +1% AER, +3% CER and Adjusted EPS of 115.9p, -6% AER, -4% CER, in line with guidance; Total EPS 115.5p, +23% AER
Highlights Strong sales performance from key growth drivers in HIV, Respiratory, Oncology and Consumer Healthcare offset disruption from COVID-19 to adult vaccinations · Pharmaceuticals £17 billion -3% AER, -1% CER; new and specialty products £9.7 billion +11% AER, +12% CER · · · New Biopharma product portfolio strengthened with 9 approvals in 2020 and Cabenuva in the US in January 2021 Effective cost control supports delivery of adjusted earnings per share in line with FY 2020 guidance · · · Significant progress on Biopharma pipeline with over 20 assets now in late-s ....
EU nod for first long-acting HIV injectable treatment 22nd December 2020 The European Commission (EC) has authorised Janssen’s Rekambys (rilpivirine injection) in combination with ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to treat HIV-1 infections in adults who are virologically suppressed. This approval marks the first time that people living in the EU with HIV can receive a long-acting injectable treatment without having to take daily oral tablets, Janssen said in a statement. The marketing authorisation is based on the phase III ATLAS, FLAIR and ATLAS-2M studies, which includes over 1,200 participants from 16 countries. “At Janssen, we are incredibly proud of this authorisation and the progress it marks in achieving our goal to address some of the biggest health threats of our time. We will continue building on our 25-year commitment to make HIV history and to change the course of the epidemic through our passionate pursuit of inn ....