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BMS/AZ’s diabetes drug among CHMP recommendations

Xigduo one of six new drugs backed in EU
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Six new drugs were recommended for use in the EU in the latest round of opinions from the Committee for Medicinal Products for Human Use (CHMP).

These new medicines include the type 2 diabetes treatment Xigduo, a combination of Forxiga (dapagliflozin) and metformin.

It is the latest treatment to come from the diabetes pact formed by AstraZeneca (AZ) and Bristol-Myers Squibb (BMS) following Forxiga, which was approved in the EU in 2012.

Xigduo aims to provide a more convenient treatment option for people with type 2 diabetes, bringing together the sodium-glucose cotransporter 2 (SGLT2) dapagliflozin and the current first-line treatment metformin, with each drug working in a different way to lower blood sugar levels.

Treatments for drug-resistant tuberculosis

Other new recommendations by the CHMP, which is part of the European Medicines Agency (EMA), included two new treatments for drug-resistant tuberculosis.

Following a re-examination of previous negative guidance, the CHMP backed Otsuka's Deltyba (delamanid) to treat pulmonary infections due to multidrug-resistant tuberculosis.

Lucane Pharma's multidrug-resistant tuberculosis treatment Para-aminosalicylic acid Lucane was also recommended by the CHMP.

Both treatments are recommended as orphan medicines due to the rarity of multidrug-resistant tuberculosis in the EU. This classification provides incentives to companies developing drugs in the area.

Cholic Acid FGK

Another orphan medicine to receive backing from the CHMP was Cholic Acid FGK from FGK Representative Service.

The drug is recommended to treat inborn errors of primary bile acid synthesis - a group of diseases in which the liver does not produce enough primary bile acids. This can lead to liver damage and failure.

Cholic Acid FGK becomes the first treatment recommended in the EU to treat the condition.

HIV and hepatitis

The remaining two new medicines recommended by the CHMP are Gilead Science's Sovaldi (sofosbuvir) for hepatitis C and ViiV Healthcare's Tivicay (dolutegravir) for HIV.

Indication extensions

In addition to the new medicines, the CHMP also recommended expanding the approved indications for Celgene's Abraxane (paclitaxel) and Boehringer Ingelheim's Pradaxa (dabigatran etexilate).

Specifically, Abraxane received a positive opinion for use in the treatment of patients with metastatic pancreatic cancer, adding to its current recommendation to treat metastatic breast cancer.

The CHMP also recommended that Pradaxa's use in the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation be expanded to include a wider group of patients.

This includes increasing the age limit on treatment from patients aged 65 to those aged 75 and losing the requirement that patients need to have a left ventricular ejection fraction of less than 40 per cent.

All recommendations will now go to the European Commission for final approval.

Article by
Thomas Meek

26th November 2013

From: Sales, Regulatory

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