Authorization

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

Regulatory News:

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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

Coronavirus Vaccine: Pfizer Says It Won’t Seek Authorization Before Mid-November

The chief executive of Pfizer said on Friday that the company would not apply for emergency authorization of its coronavirus vaccine before the third week of November, ruling out President Trump’s assertion that a vaccine would be ready before Election Day on Nov. 3.

In a statement posted to the company website, the chief executive, Dr. Albert Bourla, said that although Pfizer could have preliminary numbers by the end of October about whether the vaccine works, it would still need to collect safety and manufacturing data that will stretch the timeline to at least the third week of November.

Close watchers of the vaccine race had already known that Pfizer wouldn’t be able to meet the requirements of the Food and Drug Administration by the end of this month. But Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.

In doing so, the company had aligned its messaging with that of the president, who has made no secret of his desire for an approved vaccine before the election. He has even singled out the company by name and said he had talked to Dr. Bourla, whom he called a “great guy.”

Some scientists applauded Pfizer’s announcement.

“This is good, really good,” said Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego who was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.

He said company officials had assured him that a vaccine would most likely not be authorized before the election, but the letter Friday is “even more solid about their not being part of any political machinations.”

Dr. Bourla has pushed back against any suggestion that Pfizer’s vaccine timeline was politically motivated. In September, Pfizer was the driving force behind a pledge by nine vaccine companies to “stand with science” and not put forward anything that had not been properly vetted. Earlier this month, he published an open letter to employees that said he “would never succumb to political pressure” and expressing disappointment that “we find ourselves in the crucible of the U.S. presidential election.”

Pfizer is one of four companies testing a coronavirus vaccine in late-stage clinical trials in the United States, and it has been the most aggressive in its timeline estimates. Moderna, AstraZeneca and Johnson & Johnson have said that later in the year is more likely, matching the predictions of federal health officials. (AstraZeneca and Johnson & Johnson’s trials have been paused for potential safety concerns, which could further delay their outcomes.)

In interviews, Mr. Bourla has said that he expects a “conclusive readout” by late October, with an application for emergency authorization that could be filed “immediately.”

Pfizer’s trial of 44,000 volunteers tests the vaccine by giving one group the vaccine, another group the placebo, and waiting until a certain number of people become infected with the

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