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Monthly News Roundup - July 2018

GnRH Antagonist Orilissa OK’d for Moderate to Severe Endometriosis Pain

Endometriosis is a common gynecologic disorder associated with chronic pelvic pain in women. The FDA has now approved AbbVie’s Orilissa (elagolix), the first oral gonadotropin-releasing hormone (GnRH) antagonist for the management of moderate to severe pain associated with endometriosis. In Phase 3 studies, Orilissa significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex. Orilissa is labeled for specific treatment lengths due to a dose-dependent decrease in bone mineral density. This new endometriosis option will be available in pharmacies in early August.

Krintafel is a New Single-Dose Malaria Medicine to Prevent Relapse

In 2016 roughly 216 million cases of malaria occurred worldwide with 445,000 deaths, mostly African children, according to the CDC. Malaria, a parasitic, mosquito-borne disease can cause fever, chills, and death if left untreated. This month, the FDA approved oral Krintafel (tafenoquine), an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. In over 800 subjects, clinical efficacy and safety of the 300 mg single-dose was demonstrated by three randomized, double-blind studies from GSK and Medicines for Malaria Venture.

Tibsovo Cleared for Acute Myeloid Leukemia with IDH1 Mutation

Tibsovo (ivosidenib) is now approved for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-1 (IDH1) genetic mutation. Tibsovo, the first drug in a new class from Agios Pharmaceuticals, is an oral IDH1 inhibitor that works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), leading to differentiation of malignant cells. Studies showed that 32.8% of patients experienced a complete remission (CR) or a CR with partial hematologic recovery that lasted a median 8.2 months and a reduction in the need for transfusions. Common side effects include fatigue, joint pain, and diarrhea, among others.

Nivestym (filgrastim-aafi) is the Latest Biosimilar to Neupogen

In July, the FDA cleared Pfizer’s Nivestym (filgrastim-aafi), a biosimilar to Amgen’s Neupogen. Nivestym is a recombinant human granulocyte colony-stimulating factor injection indicated for the treatment of neutropenia associated with chemotherapy plus the other indications of the reference product. As with other biosimilars, the FDA approval was based on a review of data demonstrating a high degree of similarity of Nivestym compared to the reference product. Nivestym is Pfizer’s fourth biosimilar to be approved by the FDA, along with Retacrit (epoetin alfa-epbx), Ixifi (infliximab-qbtx), and Inflectra (infliximab-dyyb). Zarxio (filgrastim-sndz), from Sandoz, is also a biosimilar to Neupogen.

Janssen’s Single Tablet Regimen Symtuza Approved for HIV

The FDA has approved Janssen’s Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide - D/C/F/TAF), the first once daily, darunavir-based, single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. Darunavir provides a high barrier to drug resistance. In two Phase 3 studies Symtuza was compared to control regimens in treatment-naïve (AMBER) and in virologically suppressed adults (EMERALD). Symtuza was found effective and well-tolerated, with up to 95% achieving or maintaining virologic suppression (HIV-1 RNA <50c/mL) in both studies. Side effects included diarrhea, rash, nausea, fatigue, headache, stomach pain and intestinal gas.

Posted: July 2018

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