CHMP Adopts Positive Opinion of Metformin, Including Merck's Type 2 Diabetes Treatment Portfolio, in Patients with Renal Impairment

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DARMSTADT, Germany, Oct 15, 2016 /PRNewswire=KYODO JBN/ --

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    - Metformin receives positive CHMP opinion for treatment of type 2

      diabetes patients with moderate renal impairment (CKD stage 3), which

      will lead to extended treatment access

    - As the metformin originator, Merck's post-marketing efficacy and safety

      data, comprising nearly 60 years of experience, was a strong basis for

      the opinion

    - The extended treatment for the large group of type 2 diabetes patients,

      who develop advanced kidney problems, will subsequently be reflected in

      a label change of all metformin-containing products in Europe,

      including Glucophage(R) and Glucovance(R)

    Merck, a leading science and technology company, today announced that the

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines

Agency (EMA) has issued a positive opinion recommending extension of the label

for all metformin-containing products, including the Glucophage(R) product

portfolio and Glucovance(R), for the treatment of type 2 diabetes patients. The

label change will lift the contraindication for stable moderate renal failure

CKD stage 3. The maximum daily metformin dose will be 2000 mg/day in CKD stage

3a (GFR = 45-59 ml/min) and 1000 mg/day in CKD stage 3b (GFR = 30-44 ml/min),

allowing a large additional group of type 2 diabetes patients with reduced

kidney function to benefit from the treatment: In a recent analysis in CPRD, a

UK medical record database, 32.7% of all diabetic patients had CKD stage 3,

with 23.2% in CKD stage 3a and 9.5% in CKD stage 3b[1].

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    "We are pleased to know that the EMA review now confirms that metformin can

be safely used in patients with moderate renal failure," said Luciano Rossetti

MD, Executive Vice President, Global Head of Research & Development at the

biopharma business of Merck. "We are proud of our heritage in the diabetes

space that spans nearly 60 years, and began by bringing metformin to market.

Since then we, and others, have continued to research on this product, and

metformin is now amongst the best investigated oral medications for type 2

diabetes. The lift of the contraindication is, at least in part, also a result

of our research, and it further supports the safe and effective use of

metformin as first line treatment in patients with type 2 diabetes."

    Following a routine evaluation of the safety of metformin medicines, it was

found that based on scientific evidence and clinical guidelines, patients with

moderate renal failure may stand to benefit from treatment with metformin, and

that the contraindication may therefore no longer be justified. Furthermore,

the contraindication in CKD3a differed in metformin-containing products across

Europe, as Merck had been granted a lift of the contraindication in CKD stage

3a recently. Based on this evidence, the EMA issued an Article 31 referral

requesting a cumulative review of the benefit and risk in this patient group

across all metformin-selling companies in the European Union. Leveraging around

60 years of experience in market as the metformin originator, Merck supported

the EMA request by providing a comprehensive analysis of all available clinical

data on the efficacy and safety of metformin in patients with CKD stage 3. This

was balanced against a cumulative analysis of all case reports Merck has

received for lactic acidosis, the very rare risk associated with metformin

accumulation due to acute or severe renal failure. The EMA reviewed the data

submitted by all companies, and as a result, the CHMP has issued a positive

opinion on lifting the contraindication for treatment of type 2 diabetes

patients with renal impairment CKD stage 3.

    Once approved by the European Commission, the Glucophage(R) product

portfolio and Glucovance(R) will adopt this lift of contraindication for type 2

diabetes patients with moderate renal failure (CKD stage 3) through a label

change. Glucophage(R) is already today on label in patients with CKD stage 3a

in Europe and CKD stage 3 in Switzerland.

    About Glucophage(R)

    Glucophage(R) (metformin hydrochloride) is a prescription-only medicine

indicated for the treatment of type 2 diabetes mellitus, particularly in

overweight patients when diet and exercise alone have failed. In adults,

Glucophage(R) may be given alone or with oral antidiabetic agents, or with

insulin. In children from 10 years old and adolescents, Glucophage(R) may be

given alone or with insulin. A reduction of diabetic complications has been

shown in overweight type 2 diabetic adult patients treated with Glucophage(R)

as first-line therapy after diet failure. The most commonly reported side

effects with Glucophage(R) are gastro-intestinal disturbances that may occur

during treatment initiation and resolve spontaneously in most cases.

    The Glucophage(R) product portfolio comprises: Glucophage(R) IR (immediate

release) and Glucophage(R) XR (extended release). In addition, Merck produces

Glucovance(R) a fixed dose combination of metformin and glibenclamide.

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    About Merck

    Merck is a leading science and technology company in healthcare, life

science and performance materials. Around 50,000 employees work to further

develop technologies that improve and enhance life - from biopharmaceutical

therapies to treat cancer or multiple sclerosis, cutting-edge systems for

scientific research and production, to liquid crystals for smartphones and LCD

televisions. In 2015, Merck generated sales of EUR 12.85 billion in 66

countries.

    Founded in 1668, Merck is the world's oldest pharmaceutical and chemical

company. The founding family remains the majority owner of the publicly listed

corporate group. Merck holds the global rights to the Merck name and brand. The

only exceptions are the United States and Canada, where the company operates as

EMD Serono, MilliporeSigma and EMD Performance Materials.

    References

    1) McDonald HI, Thomas SL, Millett ERC, Nitsch D. CKD and the risk of

acute, community-acquired infections among older people with diabetes mellitus:

A retrospective cohort study using electronic health records. American Journal

of Kidney Diseases 2015:66:60-8

    Contact: Bettina Frank

             +49-6151-72-4660

     SOURCE: Merck