FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia

Althera Pharmaceuticals, a company focused on heart health, announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary non-familial hyperlipidemia and in adult patients with homozygous familial hypercholesterolemia. Roszet contains rosuvastatin, a powerful statin for LDL-C reduction, and ezetimibe, an efficacious cholesterol absorption inhibitor. The two components work through distinct but complimentary mechanisms to give Roszet the power to significantly lower LDL-C.

  

“The optimal LDL-C levels in guidelines across the world have been shifting lower and now many patients need to get their LDL-C below 70 mg/dL,” said Dr. Christie Ballantyne, Chief of Cardiology and Cardiovascular Research at Baylor College of Medicine. “These levels can be quite difficult to achieve with just a statin on top of diet and exercise. Rosuvastatin and ezetimibe have been extensively studied in combination therapy and have been shown to significantly reduce LDL cholesterol beyond the statin alone. Combination therapy has been widely used in hypertension to achieve lower blood pressure targets. This new therapy provides a high efficacy statin plus ezetimibe in a single once daily pill which is a powerful new option to help get patients to the desirable LDL goal without increasing pill burden or requiring addition of injectable therapies”

"With Roszet’s approval in the U.S., we reaffirm our commitment to improving cholesterol treatment options for physicians and patients," said Sanjeev Agarwal, CEO of Althera Pharmaceuticals. "We are on a mission to positively impact patients’ health. By making this highly effective medicine available and affordable, we hope to improve the long-term health of patients, including those with prior cardiovascular disease.”

While a patient's out-of-pocket costs will vary depending on insurance status, the Roszet Savings Program aims to reduce co-pays to as little as $20 per month for eligible patients with commercial insurance coverage. Althera is continuing to work with all stakeholders to ensure that Roszet is affordable and accessible to all. Please visit http://www.roszet.com for more information and updates about the Roszet Savings Program and eligibility.

Availability

Roszet will be available in pharmacies in June 2021.

Roszet Indications, Dosage and Other Select Information

Roszet is indicated, as an adjunct to diet, in adults with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C), and alone or as an adjunct to other LDL-C lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Roszet is available as a once-daily tablet with rosuvastatin/ezetimibe dosages of 5 mg/10 mg, 10 mg/10 mg, 20 mg/10 mg and 40 mg/10 mg.

https://en.wikipedia.org/wiki/Ezetimibe

https://en.wikipedia.org/wiki/Rosuvastatin

FDA Approves Qelbree (viloxazine) for the Treatment of ADHD

Supernus Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases,  announced that the U.S. Food and Drug Administration (FDA) has approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their care givers who participated in and supported our research.”

“ADHD is one of the most common mental health issues in the U.S.,” said Andrew J. Cutler, M.D., Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University, and Chief Medical Officer, Neuroscience Education Institute. “The right treatment is key for children and adolescents, as they grow and navigate school and social relationships. This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD.”

The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years. In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.

https://en.wikipedia.org/wiki/Viloxazine

Eating Mushrooms Lowers Cancer Risk

In continuation of my update on the benefits of mushrooms

 

Edible mushrooms are good for health. Now, a new study revealed that consuming mushrooms on a daily basis can lower your risk of developing cancer.

Next time you make a salad, you might want to consider adding mushrooms to it. The new Penn State study was published in Advances in Nutrition.

The systematic review and meta-analysis examined 17 cancer studies published from 1966 to 2020. Analyzing data from more than 19,500 cancer patients, researchers explored the relationship between mushroom consumption and cancer risk.

Benefits of Mushrooms

Mushrooms are rich in vitamins, nutrients and antioxidants.

The team's findings show that these super foods may also help guard against cancer.

Even though shiitake, oyster, maitake and king oyster mushrooms have higher amounts of the amino acid ergothioneine than white button, cremini and portabello mushrooms, the researchers found that people who incorporated any variety of mushrooms into their daily diets had a lower risk of cancer.

According to the findings, individuals who ate 18 grams of mushrooms daily had a 45% lower risk of cancer compared to those who did not eat mushrooms.

"Mushrooms are the highest dietary source of ergothioneine, which is a unique and potent antioxidant and cellular protector," said Djibril M. Ba, a graduate student in epidemiology at Penn State College of Medicine. 

Fight Cancer with Mushrooms

When specific cancers were examined, the researchers noted the strongest associations for breast cancer as individuals who regularly ate mushrooms had a significantly lower risk of breast cancer.

Ba explained that this could be because most of the studies did not include other forms of cancer. Moving forward, this research could be helpful in further exploring the protective effects that mushrooms have and helping to establish healthier diets that prevent cancer.

"Overall, these findings provide important evidence for the protective effects of mushrooms against cancer," said coauthor John Richie, a Penn State Cancer Institute researcher and professor of public health sciences and pharmacology.

"Future studies are needed to better pinpoint the mechanisms involved and specific cancers that may be impacted."

Eating Mushrooms Lowers Cancer Risk

FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control

In continuation of my update on drospirenone

"When speaking with patients about their contraceptive options, one of the most common concerns is side effects," said Mitchell Creinin, Professor and Director of Family Planning at the University of California, Davis. "Nextstellis is an innovative contraceptive that has been shown to be not only safe and effective, but also well tolerated in clinical trials with a desirable bleeding profile and minimal impact on triglycerides, cholesterol, and glucose, as well as weight and endocrine markers."

Nearly 10 million American women use short-acting combination contraceptives (estrogen and progestin). Of these contraceptives, more than 99% contain ethinyl estradiol (EE), a synthetic estrogen that binds widely to all estrogen receptors in the body.
Nextstellis is the only oral contraceptive to contain E4; E4 acts differently than other estrogens and is the first estrogen to be described as a NEST:  A Native Estrogen with Selective actions in Tissues. It has more selective activity in tissues, focusing on those needed to support contraceptive efficacy, cycle control and other beneficial effects of estrogen. Nextstellis pairs E4, which has a long half-life (24-28 hours), with the proven progestin drospirenone, specifically chosen due to its long half-life (~30 hours) and its anti-androgenic and anti-mineralocorticoid properties.

"The approval of Nextstellis represents an important milestone in providing women with another choice for their reproductive health," said Scott Richards, CEO of Mayne Pharma. "We are delighted to be introducing a new estrogen and bringing to market this novel, safe and effective option for women to consider with their healthcare providers."

The comprehensive Nextstellis clinical study program included a diverse patient population with women both starting and switching birth control as well as patients with a body mass index (BMI) of up to 35 kg/m2. According to phase 3 study findings, Nextstellis demonstrated contraceptive efficacy across all subgroups by age, BMI and prior hormonal contraception use. Nextstellis was also associated with a favorable bleeding profile and low rates of breakthrough bleeding, including in cycle 1.

Nextstellis was developed by Mayne Pharma's development and manufacturing partner, Mithra Pharmaceuticals, SA. The company anticipates the commercial launch of Nextstellis by the end of June 2021.

Mayne Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved Nextstellis (3 mg drospirenone [DRSP] and 14.2 mg estetrol [E4] tablets) for the prevention of pregnancy. Nextstellis is the first and only contraceptive pill containing E4, a naturally occurring estrogen, now produced from a plant source, with a unique mechanism of action that offers potential advantages over other estrogens.

https://en.wikipedia.org/wiki/Drospirenone