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Aug 28 2020
In the treatment of ulcerative colitis, Bristol Myers Squibb S1P receptor regulator has obtained new indications

Bristol Myers Squibb (BMS) announced in June that the US FDA approved zeposia (ozanimod) 0.92 mg for the treatment of moderate and severe active ulcerative colitis (UC) in adults. The press release pointed out that this is the first oral S1P receptor modulator approved for the treatment of patients with moderate and severe active UC.
This approval is based on the results of a critical phase 3 clinical trial called true north. Compared with placebo, zeposia in the 10th week of induction treatment (18.4% vs 6.0%; P < 0.0001) and at the 52nd week of maintenance treatment (37.0% vs 18.5%; P < 0.0001) significantly increased the proportion of patients with clinical remission and reached the main end point of the trial. At the same time, zeposia achieved a number of key secondary endpoints, including clinical response, endoscopic improvement, endoscopic histological mucosal improvement and so on.
Ulcerative colitis is a chronic inflammatory bowel disease (IBD), which is characterized by long-term abnormal immune response, resulting in persistent inflammation and ulcer in the mucosa of colon or rectum. Symptoms include bloody stool, severe diarrhea and frequent abdominal pain. Ulcerative colitis has a significant impact on patients’ health-related quality of life, including physical function, social and emotional health, and work ability. Many patients have insufficient or no response to the currently available treatment.
Zeposia (ozanimod) is an oral S1P receptor regulator that binds to S1P receptors 1 and 5 with high affinity. Zeposia reduces the ability of lymphocytes to leave lymph nodes and reduces the number of circulating lymphocytes in peripheral blood. It has been approved by the FDA for the treatment of multiple sclerosis. At present, the mechanism of zeposia in the treatment of ulcerative colitis has not been fully clarified, but it may involve reducing the number of lymphocytes migrating to the inflamed intestinal mucosa.
“Despite a variety of approved therapies, UC patients still have unmet needs and need additional treatment options to help them better manage the disease.” Mr. Adam lenkowsky, head of the U.S. Department of cardiovascular, immunology and oncology of Bristol Myers Squibb, said: “we are very pleased that scientific research in immunology can bring a new treatment option for UC patients with different mechanism of action from existing therapies.”

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Aug 21 2020
Abbott left atrial appendage occluder Amplatzer amulet approved by FDA

Recently, Abbott announced that its Amplatzer amulet left atrial appendage occluder has been approved by FDA. The left atrial appendage occluder helps to reduce the risk of stroke in patients with atrial fibrillation, which is one of the most common arrhythmias. The device can immediately close the left atrial appendage (LAA), which is the site where thrombosis may occur in patients with atrial fibrillation (AFib), so as to reduce the risk of stroke.


Amplatzer amulet superior performance
There are abundant comb muscles and muscle trabeculae in the left atrial appendage, and the surface is not smooth, which is easy to make the blood flow produce vortex and slow down. It is the main condition to promote thrombosis, which determines that the left atrial appendage is the prone site of left atrial thrombosis to a certain extent. The effective pumping capacity of the heart in patients with atrial fibrillation may be destroyed, causing blood to accumulate in the left atrial appendage, resulting in an increased risk of coagulation. If blood clots flow to blood vessels, they may enter the brain and cause a stroke. For patients with atrial fibrillation who cannot take blood dilution drugs for a long time, doctors can choose to block or close the left atrial appendage through minimally invasive surgery, such as Abbott’s Amplatzer ™ Amulet ™ The device completely closes the left atrial appendage to reduce the risk of stroke. Abbott said that previous clinical data showed that this product helped to reduce the number of patients with thrombosis by two-thirds every year. In these patients, more than 90% of the thrombosis leading to stroke was caused by the left atrial appendage.
“As the world’s population continues to age, we see a surge in cases of atrial fibrillation, followed by an increased risk of stroke,” said dhanunjaya Lakkireddy, M.D., HCA Midwest health Kansas City Heart Rhythm Institute The FDA approved Abbott’s Amplatzer amulet, which provides doctors with another treatment option to reduce the risk of stroke and avoids the need for hemodilution drugs immediately after surgery. Abbott’s technology is very valuable because these drugs will increase the risk of bleeding. “
Before the approval of this product, the only minimally invasive option for American doctors and their patients to block the left atrial appendage is the solution of sealing the left atrial appendage with a single component. This solution requires hemodilution drugs and additional patient monitoring equipment to ensure the accurate closure of the left atrial appendage. In contrast, Abbott’s Amplatzer amulet uses double occlusion technology to completely and immediately block the left atrial appendage, and patients do not need to use hemodilution drugs after surgery. In addition, the device can also be widely used in anatomical structure surgery, and has the most complete size range of occluder on the market; It can also be recaptured and repositioned to ensure that the device can be placed in the best position. Since the first CE Mark Approval in 2013, the Amplatzer amulet left atrial appendage occluder has been approved for use in more than 80 countries, including Europe, Canada and Australia.
Michael Dale, senior vice president of Abbott’s structural heart business, said: “Amplatzer amulet’s unique double sealing method makes it the first plugging product in the European market. Therefore, today’s FDA approval is an important milestone for Abbott, enabling us to bring this treatment scheme to more American doctors and patients.” This is consistent with our mission and goal and can help people live a healthier and better life. “


Abbott CEO Robert Ford said at the earnings conference call on July 22 that the device obtained the CE mark in 2013, accounting for 50% of the European market, which gave Abbott confidence that it could occupy a place in the U.S. market. According to a recent e-mail statement from Abbott public relations, the American left heart ear market is currently worth $500 million. At present, the product has been approved by FDA, which means that Abbott Amplatzer amulet has become the most powerful competitor of poco’s watchman equipment.
Poco’s watchman products may require patients to require hemodilution therapy for at least three months in the process of postoperative rehabilitation, which virtually increases the risk of bleeding. Abbott said that, in contrast, the design of Amplatzer amulet allows patients to completely skip the postoperative drug treatment stage. The promotion of amulet in the American left atrial appendage market is likely to shake the dominant position of Boko watchman products in the United States. Abbott plans to publish a comprehensive analysis of Amplatzer amulet and watchman at the annual meeting of the European Society of Cardiology later this month.

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