CSL share price lower despite US FDA boost

The regulator has approved a treatment for sufferers of chronic kidney disease.

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The CSL Ltd (ASX: CSL) share price is starting the week in a subdued fashion.

In early trade, the biotechnology company's shares are down 0.25% to $287.37

Why is the CSL share price falling?

Investors have been selling CSL shares on Tuesday following a soft start to the week for the stock market. This appears to have offset the announcement of some good news.

In respect to the latter, the United States Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia Therapeutics in partnership with the CSL Vifor business.

Anaemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. CSL notes that it commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin. It is a hormone that helps regulate production of red blood cells.

In light of this, anaemia due to CKD can have a profound impact on a person's quality of life. It can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, it leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.

The company notes that approval of Vafseo is based on efficacy and safety data from the INNO2VATE program and an assessment of post marketing safety data from Japan where Vafseo was launched in August 2020.

The CSL Vifor business has been granted an exclusive license to sell Vafseo to Fresenius Kidney Care dialysis centers and specific other third-party dialysis organisations in the United States. This allow CSL to potentially reach approximately 60% of the dialysis patients in the country.

'An important moment'

The General Manager of CSL Vifor, Hervé Gisserot, was pleased with the US FDA approval. He said:

We congratulate our partner Akebia on the FDA approval, which represents an important moment in our shared efforts toward improving the lives of dialysis patients with anemia due to CKD in the U.S.

As we continue to deliver on our promise for patients and public health, we are eager to closely collaborate with our partners to make this new oral treatment option available to patients.

This sentiment was echoed by the co-chair of the independent Executive Steering Committee for the PRO2TECT and INNO2VATE clinical trials, Glenn M. Chertow. He adds:

Patients receiving maintenance dialysis would benefit from additional therapeutic options that can effectively increase and maintain hemoglobin concentrations within guideline-recommended target ranges.

The CSL share price is down 2% over the past 12 months.

Motley Fool contributor James Mickleboro has positions in CSL. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has positions in and has recommended CSL. The Motley Fool Australia has recommended CSL. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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