New Drugs Approved In March

(RTTNews) - Only two novel drugs were approved by the FDA in March compared to seven drug approvals in the same month last year. Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

Trogarzo

Trogarzo received green signal from the FDA on March 6, 2018, for treatment of adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).

Developed by TaiMed Biologics USA Corp., Trogarzo (ibalizumab-uiyk) Injection is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.

The wholesale acquisition cost for Trogarzo is expected to be $118,000 annually.

Ilumya

Ilumya was approved by the FDA on March 20, 2018, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Developed by Sun Pharmaceutical Industries Inc., Ilumya (tildrakizumab-asmn) Injection is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4.

Psoriasis is a chronic immune disease that appears on the skin. Plaque psoriasis is the most common form of psoriasis, accounting for 80 to 90 percent of the cases.

Sun Pharma acquired the worldwide rights to Ilumya from Merck (MRK) in September 2014. Merck is eligible to receive milestone payments and royalties on sales of Ilumya.

Ilumya is expected to be priced around $40,000 a year.