Keeping tabs on pharma: Landmark new drug approvals and Sanofi’s diversity push

Gilead subsidiary gains approval for cell therapy in the US

The US Food and Drugs Administration (FDA) has approved a CAR T-cell therapy developed by Kite, a Gilead company, to treat lymphoma. 

Yescarta will be available as a first line of treatment to patients with large B-cell lymphoma. This follows clinical studies showing that patients treated with this therapy were 2.5 times more likely to be alive after two years without cancer progression or the need for additional cancer treatment. 

Historically, treatment has consisted of chemoimmunotherapy, followed by high-dose chemotherapy if the patient responded to it. Eventually eligible patients would receive a stem cell transplant. 

Christi Shaw, Chief Executive Officer of Kite, said: “Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey.” 

Japan is first country to fully approve AstraZeneca's treatment for major bleeding

Japan is the first country to give full regulatory approval to AstraZeneca's anticoagulant drug Ondexxya for patients experiencing a life-threatening or uncontrolled bleeding. 

It had previously received approval from the US Food and Drug Administration (FDA) under the accelerated approval pathway in May 2018, as well as conditional approval by the European Commission in April 2019. 

Ondexxya works by reversing the anticoagulant effect of FXa inhibitors apixaban,  rivaroxaban or edoxaban. They are used to prevent and treat conditions such as deep vein thrombosis and pulmonary embolism, as well as preventing stroke in patients who have an irregular heart rate. While these prevent clots from forming, they can increase the risk of major bleeding. 

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “With the approval of Ondexxya in Japan, we are working to make this important medicine available as quickly as possible for the small proportion of patients with life-threatening or uncontrolled bleeding who are on FXa inhibitors and who have not previously had an approved reversal agent treatment option.” 

Sanofi launches first-of-its-kind diversity, equity and inclusion board

Sanofi is launching a diversity, equity and inclusion (DE&I) board with external advisors. It is the first time the pharma sector has a board of this kind with outside members. 

The advisors, who are appointed for three years, include organizational psychologist and elected Fellow of the Royal Society for Public Health John Amaechi, award-winning social entrepreneur and President of the International Agency for the Prevention of Blindness Caroline Casey and Global Chief Diversity Officer for Sodexo Dr Rohini Anand.

The DE&I board’s role is to ensure Sanofi’s DE&I strategy reaches the company’s 2025 targets, that include “building representative leadership, creating a work environment where employees can bring their whole selves and engaging with the company’s diverse communities”. 

Commenting on the announcement, Dr Rohini Anand said: “I am thrilled to join Sanofi’s DE&I board as it affords me an opportunity to influence the critical need to address healthcare disparities globally.”

She added: “With my experience in leading global DE&I transformations I am motivated to support Sanofi as it seeks to foster an equitable and inclusive culture that enables breakthrough innovations because it is the desired destination for diverse talent. I am impressed by the authenticity and humility with which the leadership approaches DE&I and its willingness and openness to learn from external thought leaders.”

Also in the news: 

• University College London (UCL) researchers have found that opioid use in parts of Africa and South America is less than one tenth of one per cent of the rates in wealthier countries in North America, Europe and Australia. 
• University of Eastern Finland researchers are studying a novel microRNA drug which could be a new treatment for ischemic cardiovascular disease. Their findings show that the drug acts differently to other microRNAs by activating a cell’s own therapeutic gene. It is also believed to be more stable than mRNA-based drugs. 

Quick links:

• Discover how targeted radiotherapy induced toxicity can be identified with imaging
• Driving diversity in clinical trials
• Rewriting the human genome

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