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.

Zinplava for Clostridium difficile infection (October 21, 2016)

FDA has approved Zinplava (bezlotoxumab) Injection 25 mg/mL to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and who are at high risk for CDI recurrence. Zinplava is

not indicated for the treatment of CDI. Zinplava, manufactured by Merck & Co., Inc. is not an antibacterial drug. Zinplava should only be used in conjunction with antibacterial drug treatment of CDI. Merck expects to make Zinplava available in first quarter 2017.

Carnexiv (antiepileptic agent) (October 07, 2016)

FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is

temporarily not feasible. Developed by Lundbeck Inc., Carnexiv received orphan drug designation for this indication and will be the first available IV formulation of carbamazepine. Lundbeck plans to make Carnexiv commercially available in the U.S. in early 2017. Carnexiv is a short-term (≤7 days) intravenous replacement therapy for oral carbamazepine formulations that provides continuity of care for adult patients who are unable to take carbamazepine by mouth and who have the following seizure types:

• Partial seizures with complex symptomatology

• Generalized tonic-clonic seizures

• Mixed seizure patterns, which include the above, or other partial or generalized seizures