Johnson & Johnson has received approvals on both sides of the Atlantic for two key drugs.
First up, the US Food and Drug Administration has given the green light to Olysio (simeprevir), which was co-developed with Sweden’s Medivir. The thumbs-up comes less than a month after the agency’s Antiviral Drugs Advisory Committee voted 19-0 in favour of simeprevir in combination with pegylated interferon and ribavirin for the treatment of hepatitis C genotype 1 infections.
The approval, which followed a priority review, is based on five studies of over 2,000 people and results from one of them showed that 80% of treatment-naive participants given Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50% receiving the latter two therapies alone. In one of the studies with previously-treated patients whose infection returned, 79% on the Olysio combo achieved sustained virologic response (ie the hep C virus was no longer detected in the blood) compared to 37% of those receiving peginterferon-alfa and ribavirin.
Olysio is the third approved protease inhibitor for hep C, as the agency granted approvals to Merck & Co’s Victrelis (boceprevir) and Vertex’ Incivek (telaprevir) in 2011.
Meantime, across the pond, the European Commission has approved Invokana (canagliflozin) for type 2 diabetes. The decision is based on a Phase III trial programme, which enrolled 10,285 patients in nine studies.
Invokana, which is an oral, once-daily medication, belongs to a new class of drugs called sodium glucose co-transporter 2 inhibitors. In Europe, it will compete with AstraZeneca and Bristol-Myers Squibb’s SGLT2 inhibitor Forxiga (dapagliflozin).
Invokana was approved by the FDA in March 2013 and recently also in Australia.
