Santen Announces Positive Outcome of the European Decentralized Procedure for Approval of TAPTIQOM®
Jouni Vuorinen (jouni.vuorinen4pharma.com), Nov 3rd 2014On October 22, 2014, Santen announced the positive outcome of the decentralized procedure for TAPTIQOM® in Europe. The announcement follows the issuance of the final assessment report from the reference member state, the federal institute for drugs and medical devices of Germany, and the agreement of all the concerned member states that TAPTIQOM® is approvable. The regulatory process will now enter the national phase in which Germany and each of the concerned member states grants its national license.
TAPTIQOM® is a preservative-free eye drop solution (in single dose containers) of a fixed dose combination of the prostaglandin tafluprost (15 micrograms/ml) and the beta blocker timolol (5 mg/ml). These two components lower intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound alone. TAPTIQOM® was co-developed by Santen and Asahi Glass Co., Ltd.
TAPTIQOM® will be indicated for the reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative free eye drops.
“Santen was the first company to develop a preservative-free prostaglandin eye drop, tafluprost (TAFLOTAN®, SAFLUTAN®), back in 2008 as a response to an unmet medical need. TAPTIQOM® will complete Santen’s glaucoma portfolio of preservative-free products.” recapitulated Auli Ropo, M.D., PhD, Director, Clinical Research & Medical Affairs, Santen Oy, and added “Santen will continue to work hard to make TAPTIQOM® available as soon as possible for patients suffering from open angle glaucoma or ocular hypertension who would benefit from preservative-free eye drops”.