Three new Novartis medicines approved in Japan for patients with type 2 diabetes, high blood pressure and advanced kidney cancer
Equa, Exforge and Afinitor provide new treatment options for unmet medical needs
Patients in Japan will benefit from the approval of three new Novartis medicines - Equa® (vildagliptin), marketed as Galvus® in the European Union, for the treatment of type 2 diabetes, Exforge® (valsartan/amlodipine) for high blood pressure, and Afinitor® (everolimus) for advanced kidney cancer. These approvals reinforce the strong commitment of Novartis to helping patients in Japan, the company's second-largest pharmaceutical market.
"It is a significant achievement to secure the approval of three such important new medicines for the benefit of Japanese patients," said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. "These approvals, which follow six launches last year, mean we continue to quickly introduce innovative medicines to treat serious and life-threatening diseases affecting millions of Japanese patients and their families."
Equa has been approved in Japan for the treatment of type 2 diabetes, as monotherapy or in combination with a sulfonylurea. As a DPP-4 inhibitor, Equa works by targeting the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes.
Equa has been approved for doses of 50 mg twice daily, or 50 mg once daily, depending on the needs of the individual patient]. Patients treated with Equa 50 mg twice daily demonstrated an average reduction in HbA1c - a marker of blood glucose level - of 1.2% compared to placebo, which would bring half of them within the maximum HbA1c value of 6.5% recommended by the Japan Diabetes Society. Equa was shown to be well-tolerated with a favorable profile in terms of hypoglycemia and bodyweight.
Exforge has been approved in Japan as a single-pill combination of two treatments for high blood pressure: Diovan® (valsartan), the number one selling hypertension medication worldwide, and amlodipine, the world's most prescribed calcium channel blocker. Exforge has been shown to be effective across all grades of high blood pressure, with placebo-like tolerability. As many as nine out of 10 Exforge patients reach their blood pressure goal, with drops of up to 43 mmHg reported in patients with particularly elevated blood pressure.
Afinitor (everolimus) in tablet form has been approved in Japan for the treatment of patients with non-resectable, metastatic renal cell carcinoma (advanced kidney cancer). Each year, more than 10,000 people in Japan are diagnosed with kidney cancer.
A once-daily therapy, Afinitor provides continuous inhibition of the mTOR protein, a central regulator of tumor cell division and blood vessel growth in cancer cells. Afinitor is the first mTOR inhibitor approved to treat advanced kidney cancer patients in Japan.
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