Novartis has been boosted by the news that regulators in Japan have granted approval to four of the Swiss major’s drugs – Tasigna , Xolair Co-Dio and Lucentis.
First up, Tasigna (nilotinib) has been given the green light for the treatment of certain forms of Philadelphia chromosome-positive chronic myeloid leukaemia in patients who are resistant to Novartis’ own Gleevec/Glivec (imatinib). Secondly, Xolair (omalizumab) has been approved for treating severe bronchial asthma in adults who are uncontrolled despite use of standard medications.
Co-Dio, which combines Novartis’ Diovan (valsartan) and hydrochlorothiazide, and is sold elsewhere Co-Diovan, Co-Tareg or Diovan HCT, has been given the thumbs-up as a second-line treatment for hypertension, while Lucentis got approval for subfoveal wet age-related macular degeneration.
Joe Jimenez, chief executive of Novartis Pharma said that “it is a significant achievement to secure the approval of so many important new medicines for the benefit of Japanese patients in a single day”. The four approvals were all supported by data from clinical trials conducted in Japan.
Novartis was not the only company celebrating green lights from the Japanese Ministry of Health, Labor and Welfare. Astellas and Ono have received clearance to market minodronic acid for osteoporosis under the respective brand names of Bonoteo and Recalbon.
The regulator has also approved Dainippon Sumitomo’s Trerief (zonisamide) for Parkinson’s disease. It has been on the market as an antiepileptic agent, under the name Excegran since 1989.
Finally Takeda has received approval from the MHLW for Ecard, which combines Blopress (candesartan cilexetil) and hydrochlorothiazide for treatment of hypertension.
