Breaking News
January 22, 2019 - New machine learning algorithms identify early symptoms of urinary tract infections
January 22, 2019 - A global influenza pandemic high on the WHO’s agenda
January 22, 2019 - Amgen Makes All Repatha (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price
January 22, 2019 - Elastronics—hydrogel-based microelectronics for localized low-voltage neuromodulation
January 22, 2019 - Branched-chain amino acids in tumors can be targeted to prevent and treat cancer
January 22, 2019 - Fueling macrophages with energy to attack and eat cancer cells
January 22, 2019 - Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)
January 22, 2019 - Does being bilingual make children more focused? Study says no
January 22, 2019 - Study reveals new genes and biological pathways linked to osteoarthritis
January 22, 2019 - FSU study provides better understanding of spinal cord injuries
January 22, 2019 - Delaying bath for newborn babies increases breastfeeding rates, finds study
January 21, 2019 - WHO identifies non-communicable diseases as major threat to human health
January 21, 2019 - Many parents still try non-evidence-based cold prevention methods for children
January 21, 2019 - High Levels of Activity, Motor Ability Linked to Better Cognition
January 21, 2019 - Killer blows? Knockout study of pair of mouse MicroRNA provides cancer insight
January 21, 2019 - Buffalo researchers receive grant to quicken development of generic equivalents of contraceptives
January 21, 2019 - One-third of pregnant women do not believe cannabis is harmful to their fetus
January 21, 2019 - Fiderstat could be used as chemopreventative drug for intestinal cancers caused by APC gene mutations
January 21, 2019 - Modifying healthcare delivery practices may improve discussions between youth and healthcare providers
January 21, 2019 - UNIST researcher named as recipient of Merck’s 2018 Life Science Awards
January 21, 2019 - How Getting a Flu Shot Could Save Your Life
January 21, 2019 - Surgical adhesions can be treated, prevented in mice
January 21, 2019 - Increased physician-targeted marketing associated with higher opioid overdose deaths
January 21, 2019 - Researchers uncover specific microbial signatures of intestinal disease
January 21, 2019 - Researchers discover new blood vessel system in bones
January 21, 2019 - Simple blood test reliably detects signs of Alzheimer’s damage before symptoms
January 21, 2019 - Study to investigate new targeted oral treatments for severe asthma
January 21, 2019 - Plan Your Plate | NIH News in Health
January 21, 2019 - Fecal occult blood test may improve CRC outcomes in some
January 21, 2019 - Blood test detects Alzheimer’s disease years before symptoms develop
January 21, 2019 - Mount Sinai joins with Paradigm and ReqMed to repurpose drug for treatment of MPS
January 21, 2019 - FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
January 21, 2019 - The causes and complications of snoring
January 21, 2019 - Placenta adapts and compensates when pregnant mothers have poor diets or low oxygen
January 21, 2019 - New implant could restore the transmission of electrical signals in injured central nervous system
January 21, 2019 - Rapid-acting fentanyl test strips found to be effective at reducing overdose risk
January 21, 2019 - Coronary Artery Calcium May Help Predict CVD in South Asians
January 21, 2019 - The mystery of the super-ager
January 21, 2019 - Scientists develop smart microrobots that can change shape depending on their surroundings
January 21, 2019 - Keep Moving to Keep Brain Sharp in Old Age
January 21, 2019 - Despite progress, gay fathers and their children still structurally stigmatized
January 21, 2019 - New drug for treating liver parasites in vivax malaria
January 21, 2019 - Merck recognized with 2018 Life Science Industry Award for best use of social media
January 21, 2019 - Coeur Wallis equips the canton of Valais with 260 SCHILLER defibrillators
January 21, 2019 - Scientists propose quick and pain-free method for diagnosing kidney cancer
January 21, 2019 - Signs of memory loss could point to hearing issues
January 21, 2019 - HeartFlow Analysis shows highest diagnostic performance for detecting coronary artery disease
January 21, 2019 - How Much Caffeine is Too Much?
January 21, 2019 - Take a timeout before you force your child to apologize
January 21, 2019 - Scientists design two AI algorithms to improve early detection of cognitive impairment
January 21, 2019 - Novel therapy for children with chronic hormone deficiency provides lifeline for parents
January 21, 2019 - Bioethicists call for oversight of poorly regulated, consumer-grade neurotechnology products
January 21, 2019 - Study shows hereditary hemochromatosis behind many cancers and joint diseases
January 21, 2019 - Short bouts of stairclimbing throughout the day can improve cardiovascular health
January 20, 2019 - Liver Transplant Survival May Improve With Race Matching
January 20, 2019 - Study implicates hyperactive immune system in aging brain disorders
January 20, 2019 - Cancer Diagnosis May Quadruple Suicide Risk
January 20, 2019 - Parkinson’s disease experts devise a roadmap
January 20, 2019 - Research brings new hope to treating degenerative brain diseases
January 20, 2019 - Scientists pinpoint a set of molecules that wire the body weight center of the brain
January 20, 2019 - Researchers get close to developing elusive blood test for Alzheimer’s disease
January 20, 2019 - UCLA researchers demonstrate new technique to develop cancer-fighting T cells
January 20, 2019 - Researchers discover how cancer cells avoid genetic meltdown
January 20, 2019 - Exercise makes even the ‘still overweight’ healthier: study
January 20, 2019 - University of Utah to establish first-of-its-kind dark sky studies minor in the US
January 20, 2019 - School-based nutritional programs reduce student obesity
January 20, 2019 - Improved maternity care practices in the southern U.S. reduce racial inequities in breastfeeding
January 20, 2019 - New enzyme biomarker test indicates diseases and bacterial contamination
January 20, 2019 - Republican and Democratic governors have different visions to transform health care, say researchers
January 20, 2019 - Researchers discover that spin flips happen in only half a picosecond in the course of a chemical reaction
January 20, 2019 - Suicide Risk Up More Than Fourfold for Cancer Patients
January 20, 2019 - Doctors find 122 nails in Ethiopian’s stomach
January 20, 2019 - UV disinfection technology eliminates up to 97.7% of pathogens in operating rooms
January 20, 2019 - Researchers discover mechanism which drives leukemia cell growth
January 20, 2019 - AHA: Infection as a Baby Led to Heart Valve Surgery for Teen
January 20, 2019 - Injection improves vision in a form of childhood blindness
January 20, 2019 - Multiple sclerosis therapies delay progression of disability
January 20, 2019 - New study finds infrequent helmet use among bike share riders
January 20, 2019 - Clearing up information about corneal dystrophies
January 20, 2019 - Researchers describe new behavior in energy metabolism that refutes existing evidence
FDA approves new drug to treat thrombocytopenia in adults with chronic liver disease

FDA approves new drug to treat thrombocytopenia in adults with chronic liver disease

image_pdfDownload PDFimage_print

The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.

“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” 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. “Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”

Platelets (thrombocytes) are colorless cells produced in the bone marrow that help form blood clots in the vascular system and prevent bleeding. Thrombocytopenia is a condition in which there is a lower-than-normal number of circulating platelets in the blood. When patients have moderately to severely reduced platelet counts, serious or life-threatening bleeding can occur, especially during invasive procedures. Patients with significant thrombocytopenia typically receive platelet transfusions immediately prior to a procedure to increase the platelet count.

The safety and efficacy of Doptelet was studied in two trials (ADAPT-1 and ADAPT-2) involving 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. The trials investigated two dose levels of Doptelet administered orally over five days as compared to placebo (no treatment). The trial results showed that for both dose levels of Doptelet, a higher proportion of patients had increased platelet counts and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to seven days following the procedure as compared to those treated with placebo.

The most common side effects reported by clinical trial participants who received Doptelet were fever, stomach (abdominal) pain, nausea, headache, fatigue and swelling in the hands or feet (edema). People with chronic liver disease and people with certain blood clotting conditions may have an increased risk of developing blood clots when taking Doptelet.

This product was granted Priority Review, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

The FDA granted this approval to AkaRx Inc.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608320.htm

Posted in: Medical Condition News | Pharmaceutical News

Tags: Bleeding, Blood, Bone, Bone Marrow, Clinical Trial, Cosmetics, Drugs, Edema, Fatigue, Fever, Headache, Health and Human Services, Hematology, Liver, Liver Disease, Nausea, Oncology, Pain, Placebo, Platelets, Public Health, Research, Stomach, Thrombocytopenia, Tobacco, Vascular, Veterinary

Tagged with:

About author

Related Articles