ASTRAZENECA - First in class Forxiga (dapagliflozin) approved in Europe – Diabetes portfolio may heal AstraZeneca’s pains
BMY and AstraZeneca jointly announced the approval of its First in class SGLT-2 inhibitor Forxiga (Dapagliflozin) once daily for the treatment of Type 2 diabetes in Europe. With regard to the US approval, company expects to resubmit its NDA by mid 2013. Hence the US approval should come in by 2014. The launch timings of Dapagliflozin in the Europe has not been confirmed by the company due to negotiation of pricing in different countries. Weight loss benefit, low rates of hypoglycemia and a solid efficacy as a combination drug due to unique mechanism that is complementary to existing drugs will allow rapid uptake for Forxiga. A first mover advantage should allow Forxiga consolidate its position ahead of competitors - a couple of which appears to have a more robust clinical profile. We project a 7 to 8 percent market share for this class of drugs, with JNJ’s canagliflozin taking the majority share (3-4%), while Forxiga clinical profile being not as strong may take around 2 percent share, which should translate into peak sales of $1.5 billion.
