FDA Approved the First-Ever Drug To Treat All Six Major Strains of Hepatitis C (or HCV) in just 8 weeks.

On 3rd August 2017,  FDA approved the first-ever drug that can treat all six major strains of hepatitis C (or HCV) in just eight weeks on Thursday.

The approval of AbbVie's Mavyret is bad news for competitors like biotech giant Gilead, whose hep C treatments are an integral part of its product portfolio. 

"This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past," the FDA's Dr. Edward Cox in a statement Thursday.

Vyxeos Approved For the Treatment of Adults with Two Types of Acute Myeloid Leukemia (AML)

 On the 3rd August, 2017, The U.S. Food and Drug Administration approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). 

Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.

“This is the first approved treatment specifically for patients with certain types of high-risk AML,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. 

“Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately.”

The FDA granted the approval of Vyxeos to Jazz Pharmaceuticals.

Imbruvica has an additional indication

FDA Approves Treatment For Chronic Graft Versus Host Disease (cGHVD)

On 2nd August 2017, FDA cleared Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD). This is the first FDA-approved therapy for the treatment of cGVHD. Imbruvica also received an Orphan Drug designation for this indication.  The FDA granted the approval of Imbruvica to Pharmacyclics LLC. 

cGVHD is a life-threatening condition that can occur in patients after they receive a stem cell transplant from blood or bone marrow, called hematopoietic stem cell transplantation (HSCT), to treat certain blood or bone marrow cancers. cGVHD occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues. Symptoms of cGVHD can occur in the skin, eyes, mouth, gut, liver and lungs. The condition is estimated to occur in 30-70 percent of all patients who receive HSCT.

The efficacy and safety of Imbruvica for the treatment of cGVHD were studied in a single-arm trial of 42 patients with cGVHD whose symptoms persisted despite standard treatment with corticosteroids. Most patients’ symptoms included mouth ulcers and skin rashes, and more than 50 percent of patients had two or more organs affected by cGVHD. In the trial, 67 percent of patients experienced improvements in their cGVHD symptoms. In 48 percent of patients in the trial, the improvement of symptoms lasted for up to five months or longer.

Common side effects of Imbruvica in patients with cGVHD include fatigue, bruising, diarrhea, low levels of blood platelets (thrombocytopenia), muscle spasms, swelling and sores in the mouth (stomatitis), nausea, severe bleeding (hemorrhage), low levels of red blood cells (anemia) and lung infection (pneumonia).

Serious side effects of Imbruvica include severe bleeding (hemorrhage), infections, low levels of blood cells (cytopenias), irregular heartbeat (atrial fibrillation), high blood pressure (hypertension), new cancers (second primary malignancies) and metabolic abnormalities (tumor lysis syndrome). Women who are pregnant or breastfeeding should not take Imbruvica because it may cause harm to a developing fetus or a newborn baby.

Celgene's Big Win

Celgene's Big Win | FDA Approved AML Drug

FDA approved Leukemia treatment developed by Celgene and Agios on 1st August 2017. The drug will now be sold as Idhifa. Idhifa is the first and only FDA-approved therapy for patients with an IDH2 mutation, a group that accounts for 8 to 19 percent of all AML patients. In the United States, that translates to about 1,200 to 1,500 patients, Celgene said.

Celgene entered its cancer-metabolism partnership with Agios back in 2010, picking up global development and commercialization rights to the candidate. The partners will co-market the drug in the U.S., and “Celgene will reimburse Agios for costs incurred for its co-commercialization efforts,” according to a release.

Oppenheimer's Leah Rush Cann said in a client note that the drug could generate sales of $1.4 billion in 2021.

The relationship paid off nicely for Celgene. The journey from first-in-human testing to a regulatory filing took just three years, an incredibly fast speed in R&D. And Agios plans to do that again with other drugs in its pipeline. Leerink’s says it’s a big step for both companies, which will be followed closely during the market launch.

The relationship paid off nicely for Celgene. The journey from first-in-human testing to a regulatory filing took just three years, an incredibly fast speed in R&D. And Agios plans to do that again with other drugs in its pipeline. Leerink’s says it’s a big step for both companies, which will be followed closely during the market launch.