GlaxoSmithKline PLC (LON:GSK) has received approvals in the UK and US for two separate treatments.
The UK healthcare cost regulator has approved GSK's gene therapy for adenosine deaminase deficiency while the US Food and Drug Administration has approved its shingles vaccine.
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Britain’s National Institute for Health and Care Excellence (NICE) said in draft guidance that the Strimvelis gene therapy improves overall survival in patients with adenosine deaminase deficiency, or ADA-SCID, compared with standard stem cell transplant therapy.
ADA-SCID is an inherited condition that affects the immune system and leads to serve combined immunodeficiency. The condition has become known as the 'bubble boy' syndrome because children with ADA-SCID need to be kept in isolation to avoid infection.
NICE approved GSK’s therapy despite a price tag of almost €600,000 for the treatment.
Strimvelis is a life-long treatment that is comparable to the combined costs of alternative treatments currently being offered by other drugmakers at a typically hefty price.
“Strimvelis represents an important development in the treatment of ADA-SCID, offering the potential to cure the immune aspects of the condition and avoid some of the disadvantages of current treatments,” NICE said.
“Costing €594,000, the treatment is usually given once only and the effects are thought to be life-long,” it added.
FDA approves shingles vaccine
GSK also announced in a statement that the US FDA has approved its Shingrix vaccine, for the prevention of shingles in adults aged 50 and older.
Shingrix is injected directly into the muscle in two doses to prevent shingles, an infection that causes a painful rash and affects one in three people in the US.
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The US FDA approval followed a successful Phase II clinical trial with more than 38,000 people, which showed efficacy against shingles greater than 90% across all age groups and sustained efficacy over a follow-up period of four years.
In preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles.
“Shingrix represents a significant scientific advancement in the field of vaccinology,” said Dr. Thomas Breuer, senior vice president and chief medical officer of GSK Vaccines.
The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at a meeting on 25 October.
If approved by the ACIP, Shingrix will be available shortly, said GSK. Shingrix was approved in Canada on 13 October while regulatory filings in the European Union, Australia and Japan are underway.