The filing of the Avanafil NDS is an important next step in solidifying our presence in men's health.
The safety and efficacy of Avanafil is supported by four randomized, double-blind, placebo-controlled, parallel trials, which included subjects with erectile dysfunction from either a general ED population, ED patients with diabetes or ED patients following bilateral nerve-sparing radical prostatectomy.
In all Phase 3 trials, statistically significant improvement in the primary efficacy measures were observed and were maintained throughout the 8-12-week treatment period.
This included statistically significant improvements of +40% to +75% in the erectile function domain of the International Index of Erectile Function.
Avanafil treatment produced statistically significant increases in vaginal penetration (up to 77%, p
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Aprecia names new chief commercial officer
Insulet's Omnipod 5 integration with Abbott FreeStyle Libre 2 Plus Sensor secures CE Mark approval
Kyowa Kirin enrols first subject in phase two tivozanib eye drops (KHK4951) clinical trial
Novo Nordisk to boost manufacturing capacity with acquisition of three fill-finish sites
Breye Therapeutics commences phase 1b/2a danegaptide clinical trial
DexCom Inc breaks ground on new manufacturing facility in Ireland
VibroSense Dynamics AB secures provisional patent for chemotherapy-induced nerve damage prediction
Innovent Biologics signs collaboration agreement with Sanegene Bio USA
Japan approves GSK's filing for Arexvy vaccination for at-risk adults
Arecor Therapeutics plc extends collaboration with Eli Lilly
OptiBiotix Health partners with Ravenswood for SlimBiome distribution in Australia and New Zealand
Boehringer Ingelheim granted European approval of oral liquid medication for feline diabetes