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FDA clears Isentress formulation for infants with HIV

Merck's integrase inhibitor available for children as young as four weeks
Merck and Co - US headquarters

A new formulation of Merck & Co's drug Isentress has been cleared in the US to treat infants and children with HIV infection.

The US Food and Drug Administration (FDA) approved a paediatric formulation of the product that comes in an oral suspension formulation, meaning it contains undisolved particles of the medicine mixed with a liquid for oral administration.

The approval covers the use of this Isentress (raltegravir) formulation in children as young as four weeks of age who weigh at least 3kg.

The drug has been available in the US since 2007 when it was cleared, via the accelerated approval process, as the first integrase inhibitor available to treat HIV patients. This approval covered patients aged 16 years and over.

Merck has since been able to expand further the approved indications for Isentress, including a chewable version for children as young as two years of age that was approved at the beginning of 2012.

Now the US pharma giant has managed to lower this age even further, with executive director of clinical research Hedy Teppler saying he was “very pleased” by the latest FDA decision.

The company expects the new oral suspension formulation to be made available in the US during the third quarter of 2014.

By expanding the potential audience of Isentress, Merck will hope it can keep up in an increasingly competitive market for HIV drugs.

Tivicay (dolutegravir) – a fellow integrase inhibitor developed by the GlaxoSmithKline/Pfizer/Shionogi joint venture ViiV Healthcare – was approved in the US in combination with other antiretroviral agents to treat patients aged 12 years and older in August last year. Studies have demonstrated that a once-daily dose of Tivicay is equivalent to twice-daily treatment with Isentress in previously-untreated HIV patients.

Another of the leaders in the field is Gilead Sciences, which won FDA approval in August 2012 for its four-in-one combination drug Stribild. However, the integrase inhibitor in this combination - elvitegravir - was turned down by the FDA for use as monotherapy in May 2013 due to “deficiencies in documentation and validation of certain quality testing procedures and methods”.

10th January 2014

From: Sales

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