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VFMCRP and ChemoCentryx announce European Medicines Agency has accepted to review the Marketing Authorization Application for avacopan

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201102005955/en/

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Ltd. and ChemoCentryx, Inc., today announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for avacopan for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangitis (GPA) and microscopic polyangiitis (MPA)), a group of rare and severe autoimmune diseases with high need for targeted therapies.

If approved, avacopan would be the first orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis. Data from the global pivotal phase-III ADVOCATE trial demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group. In the trial, the avacopan group also showed significantly lower glucocorticoid toxicity, greater improvement in kidney function and greater improvement in health-related quality of life measures compared to the prednisone group.

The EMA will review the application under the centralized marketing authorization procedure. If approved avacopan would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. Approval is expected H2, 2021.

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit viforpharma.com

About ChemoCentryx
ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis.

ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.

About ADVOCATE and ANCA-Associated Vasculitis
The ADVOCATE trial of avacopan was a global double-blind double-dummied Phase III trial of 331 patients with ANCA-associated vasculitis (ANCA vasculitis) in 20 countries.

ANCA vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as a major target. Treatment for ANCA vasculitis consists of courses of immuno-suppressants (cyclophosphamide or rituximab), combined with high-dose and often prolonged use of glucocorticoids which can be associated with significant adverse events. ANCA vasculitis is relapsing and remitting long term condition and patients are at

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health

YouTube influencers are marketing junk food to kids

The study demonstrates how advertisers are seeking to take advantage of new avenues to market their wares to children.

“We should approach YouTube influencer videos with skepticism, even with videos that seem to be educational or kid-friendly,” said senior author Marie Bragg, an assistant professor of public health nutrition with joint appointments at New York University’s School of Global Public Health and Langone Medical Center.

Of the 418 YouTube videos that fell within their search criteria, the researchers found that 179 of the videos featured food or drinks, with 90% of those instances showing unhealthy branded items, such as fast food.

Those specific YouTube videos were viewed more than a billion times.

A new kind of marketing

Keeping track of what types of food advertising children are exposed to is important. That’s because dietary habits during childhood can have a significant effect on their likelihood of their becoming obese or developing cardiovascular disease and Type 2 diabetes later in life, according to past research.

And while much food advertising takes place on television, companies have increasingly turned to the growing audiences on social media sites such as YouTube.

One of the most important aspects of the study, Bragg said, was simply bringing attention to the fact that YouTube’s most popular under-18 hosts are frequently promoting products directly, and kids are often glued to the message.

“This kind of marketing is uncharted territory for families and researchers,” she said. Parents “may think they’re setting their kids down to watch another kid play in their backyard,” not children promoting Chicken McNuggets for a fee.

That’s particularly true during the pandemic with parents turning to screen time to keep kids occupied when there are fewer in-person activities and parents are working from home.

“Child exposure to unhealthy food, beverage, and other content on YouTube needs to be regulated,” said Dr. Jenny Radesky, lead author of the American Academy of Pediatrics policy statement on digital advertising to children, via email. “‘Host-selling’ — the practice of trusted characters promoting products within their own videos — needs to stop on YouTube, because it’s not allowed on TV.” Radesky was not involved in the study.
One major type of YouTube influencer video, which can feature food, is the phenomenon known as “unboxing videos,” in which people open up boxes of products while they narrate or comment on what they’re doing. The videos can blur the line between a product review and advertising outright.

“While the adult digital ecosystem is driven by ad revenue and persuasive design, that doesn’t mean that children’s digital spaces should be,” added Radesky, who is also an assistant professor of pediatrics at the University of Michigan. “We need a new children’s design code of ethics in the US.”

One popular YouTube channel, Ryan’s World, which was one of the five major influencer channels featured in the study, boasts more than 26 million subscribers. It features videos with food and stars a young boy who frequently plays with toys on screen.
“Parents shouldn’t allow
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