FDA clears new indication for Promacta
The Food and Drug Administration has expanded the use of Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients age 2 years old and older with severe aplastic anemia, or SAA, in combination with standard immunosuppressive therapy, or IST.
Promacta is an oral thrombopoietin receptor agonist that is already approved for SAA for patients who have had an insufficient response to IST. It also is approved for adults and children with chronic immune thrombocytopenia who are refractory to other treatments, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus, or HCV infection.
“Severe aplastic anemia can be a fatal diagnosis if left untreated, and many patients fail to respond to current initial treatment options,” Novartis Oncology CEO Liz Barrett said. “Today’s U.S. approval for Promacta is an important step forward for people living with this challenging disease and shows how Novartis continues to reimagine care in areas where few treatment options exist.”
SAA is a rare, life-threatening, acquired blood disorder in which a patient’s bone marrow fails to produce enough red blood cells, white blood cells and platelets. As a result, people living with this serious disease may experience such debilitating symptoms and complications as fatigue, trouble breathing, recurring infections, and abnormal bruising or bleeding that can limit their daily activities.
The FDA also granted Promacta Breakthrough Therapy designation as a countermeasure for hematopoietic sub-syndrome of acute radiation syndrome, or radiation sickness, which occurs after exposure to ionizing radiation and leads to many symptoms including thrombocytopenia.
Aries gets FDA green light for Aemcolo
Aries Pharmaceuticals has received the Food and Drug Administration’s clearance for Aemcolo (rifamycin) 194 mg delayed-release tablets, a new minimally absorbed antibiotic that is delivered to the colon for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of E. coli.
In October 2017, the FDA granted Qualified Infectious Disease Product and Fast Track designations for Aemcolo.
The product will be available in pharmacies in the first quarter of 2019, the company said
“Travelers’ diarrhea can be highly disruptive and cause significant discomfort for patients, and, in some cases, it can progress to more serious conditions if not treated effectively. The recent approval of Aemcolo is an important step for Aries as we continue to grow our portfolio to address important unmet needs in the GI community,” Aries Pharmaceuticals CEO Tom Joyce said.
Indivior gets FDA nod for Perseris
The Food and Drug Administration has given the OK for Indivior’s Perseris (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults.
Perseris contains risperidone, a well-established medicine for schizophrenia, and uses an extended-release delivery system to form a subcutaneous depot that provides sustained levels of risperidone over one month.
“The availability of Perseris provides physicians with a new treatment option to help address some of the challenges in treating schizophrenia,” Indivior’s CEO Shaun Thaxter said. “We understand the complex patient journey of people living with schizophrenia and recognize the important role that long-acting injectables can play. Perseris is a demonstration of our ongoing commitment to developing innovative treatments for people living with this debilitating condition.”