FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients

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Axurity Pharmaceuticals announced that the FDA has officially approved Myhibbin as a ready-to-use mycophenolate mofetil oral suspension for organ transplant patients. Myhibbin is the first FDA-approved liquid formulation of mycophenolate, which is used to avoid organ rejection in transplant recipients, according to Azurity. The company stated that this approval provides a significant new option for both pediatric patients above the age of three months and adults who have undergone kidney, heart, or liver transplants.¹

"We are very pleased that adult and pediatric organ transplant recipients will soon have access to the only FDA-approved ready-to-use oral liquid formulation of mycophenolate," said Richard Blackburn, CEO, Azurity Pharmaceuticals, in a press release. "Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines. Myhibbin's ready-to-use formulation provides patients, pharmacists, and caregivers an alternative to other mycophenolate dosage forms."

According to the National Kidney Foundation, most people who receive a new kidney are required to take immunosuppressants. However, there are scenarios in which this won’t be needed, such as if the donor was the recipient’s identical twin. The foundation suggests that even missing a single dose could mean that the body will reject the new organ completely. Other symptoms of rejection include a fever above 100 degrees, weight gain, bloody urine, and less of a urine output.²

“When you get a kidney transplant, your body knows that the new kidney is foreign (that is, not originally part of your body). Your body will attack the new kidney and try to damage or destroy it. The immunosuppressant drugs suppress your body's ability to do this,” reports the National Kidney Foundation. “The goal is to adjust these drugs to prevent rejection and to minimize any side effects of the drugs.”

Currently, there are several different drugs used after an organ transplant, according to the National Kidney Federation. The most common immunosuppressants include tacrolimus, ciclosporin, azathioprine, mycophenolate, and prednisolone. While they are all used differently, nobody will take all five of them, with tacrolimus being the most commonly prescribed.³

“Many drugs are prescribed in the first few months after a transplant. Some of these are the immuno-suppressant drugs discussed above,” reported the National Kidney Federation. “Others are drugs given to prevent infection or stomach ulcers, many of which are stopped at 6 months or a year after the transplant. Other drugs are given because of side effects such as high blood pressure or high cholesterol levels. So, although EPO, phosphate binders and anti-itching drugs needed on dialysis can usually be stopped soon after a transplant, the total number of tablets you need to take will often be increased.”

References

1. AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF MYHIBBIN™ (mycophenolate mofetil oral suspension). PR Newswire. May 6, 2024. Accessed May 6, 2024. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-myhibbin-mycophenolate-mofetil-oral-suspension-302136879.html

2. 7 Things to know about immunosuppressants. National Kidney Foundation. Accessed May 6, 2024. https://www.kidney.org/atoz/content/immuno

3. What drugs are needed after transplantation? National Kidney Federation. Accessed May 6, 2024. https://www.kidney.org.uk/what-drugs-are-needed-after-transplantation