Novartis Receives Japanese Approval For Three New Medicines

Novartis has received Japanese approval for three of its medicines: Equa (vildagliptin), Exforge (va

Equa, marketed as Galvus in the EU, has been approved in Japan for the treatment of type 2 diabetes, as a 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.

Reportedly, Equa has been approved for doses of 50mg twice daily, or 50mg once daily, depending on the needs of the individual patient. Patients treated with Equa 50mg twice daily demonstrated an average reduction in HbA1c, of 1.2% compared to placebo. Equa was shown to be well-tolerated with a favourable profile in terms of hypoglycaemia and bodyweight.

The company said that Exforge has been approved as a single-pill combination of two treatments for high blood pressure, Diovan (valsartan) and Amlodipine in Japan. Exforge has been shown to be effective across all grades of high blood pressure with placebo-like tolerability. The study result showed nine out of 10 Exforge patients reach their blood pressure goal, with drops of up to 43mmHg reported in patients with particularly elevated blood pressure.

Furthermore, Afinitor (everolimus) in tablet form, has got approval for the treatment of patients with non-resectable, metastatic renal cell carcinoma in Japan. Novartis has reported that Afinitor, a once-daily therapy provides continuous inhibition of the mTOR protein. Afinitor is the first mTOR inhibitor approved to treat advanced kidney cancer patients in Japan.

The company said that the approval of Afinitor is based on RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) international phase III trial. The trial included patients from 14 trial sites across Japan.

RECORD-1 showed that Afinitor, when compared with placebo, more than doubled the median time without tumour growth or death in patients with advanced kidney cancer, whose disease progressed following earlier VEGF-targeted therapy (4.9 vs. 1.9 months, p<0.0001).

Joe Jimenez, CEO of pharmaceuticals division at Novartis, said: "It is a significant achievement to secure the approval of three such important new medicines for the benefit of Japanese patients. These approvals, which follow six launches last year, mean we continue to quickly introduce medicines to treat serious and life-threatening diseases affecting millions of Japanese patients and their families."