SMC Approves Bristol-Myers Squibb’s Daklinza and Yervoy

SMC Approves Bristol-Myers Squibb's Daklinza and YervoyScotland’s regulatory advisory committee, the Scottish Medicines Consortium (SMC) have granted approval to Bristol-Myers Squibb’s Daklinza and Yervoy for use on the NHS in Scotland.

Specifically, Daklinza (daclatasvir) received regulatory approval for use with other drugs for the treatment of chronic hepatitis C virus infection in adults.

The approval grants access to Daklinza as a treatment for patients with hepatitis C genotypes 1, 3 and 4, when used alongside other agents, including sofosbuvir.

The announcement means that patients in Scotland with chronic hepatitis C can gain access to an oral treatment regimen, which does not include interferon.

Johanna Mercier, Bristol-Myers Squibb’s UK and Ireland general manager, commented that the “decision represents another significant landmark in the fight against hepatitis C and reinforces Scotland’s commitment to treating those impacted by this serious disease.”

Mercier also noted that “Daclatasvir was the first NS5A inhibitor to be approved in Europe,” adding that it is “encouraging that the value this medicine can bring is being recognised and that Scottish patients will now be able to potentially benefit from it.”

Yervoy Regulatory Approval

Yervoy has also been granted regulatory approval to treat adult patients in Scotland with previously-untreated (first-line) advanced (unresectable or metastatic) melanoma.

Yervoy is a fully human monoclonal antibody, which works by stimulating the body’s own immune system to fight cancer.

The treatment received European regulatory approval to treat advanced (unresectable or metastatic) melanoma in adults, in July 2011.


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