J&J’s Olysio and Invokana Receive Regulatory Approval

Johnson & Johnson (J&J) has announced that they have received regulatory approvals on both sides of the Atlantic for Olysio and Invokana.

The US regulatory body, the Food and Drug Administration (FDA), approved Olysio (simeprevir) on Friday to treat chronic hepatitis C virus infection.  The drug was co-developed with Sweden’s Medivir.

The approval is under a month after the FDA’s Antiviral Drugs Advisory Committee voted in favour of Olysio in combination with pegylated interferon and ribavirin for the treatment of hepatitis C genotype 1 infections.

The regulatory approval, which followed a priority review, was based on five clinical studies with over 2,000 people.  Results from one of the clinical trials demonstrated 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 clinical studies, with previously-treated patients whose infection returned, 79% of patients on the Olysio combo achieved sustained virologic response (i.e. the hepatitis C virus was no longer detected in the blood), in comparison to 37% of those receiving peginterferon-alfa and ribavirin.

Olysio is the third approved protease inhibitor for hepatitis C, after the US regulatory agency granted approvals to Merck & Co’s Victrelis (boceprevir) and Vertex’ Incivek (telaprevir) in 2011.

Invokana Regulatory Approval

Meanwhile, the European Commission also announced on Friday that they have approved Invokana (canagliflozin) for type 2 diabetes.  The approval was centred on a Phase III clinical trial programme, which enrolled 10,285 patients in nine different clinical 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 (BMS-512148).

Invokana was approved by the FDA in March 2013 and was also recently approved by Australia’s regulatory body.


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