Spotlight on five new drugs
Soliqua for Type 2 Diabetes (November 21, 2016)
FDA has approved Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide. Soliqua 100/33, from Sanofi, a once-daily
injection, was studied in a Phase 3 program of more than 1,900 patients. Soliqua 100/33 showed better HbA1c lowering versus Lantus in a majority of the 736 patients (55% vs. 30%). It will
be delivered in a single pre-filled pen for once-daily dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20 mcg of lixisenatide.
Intrarosa for dyspareunia (November 17, 2016)
Intrarosa, from Endoceutics, Inc., a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome
symptom of vulvar and vaginal atrophy. The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.
Lartruvo for soft tissue sarcoma (October 19, 2016)
FDA has granted accelerated approval for Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS). Lartruvo, manufactured by Eli Lilly and Company is approved in combination with doxorubicin for patients with STS that cannot
be cured with radiation or surgery or for which an anthracycline (chemotherapy) is an appropriate treatment. Lartruvo is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody. When stimulated, PDGF receptors cause tumor growth. Lartruvo blocks these receptors.