Therapeutic areas in focus
AstraZeneca’s liver cancer treatment gets FDA approval
Cambridge, UK-based pharmaceutical company AstraZeneca has announced that its Imjudo treatment for adults with unresectable liver cancer has gained FDA approval. The treatment is to be used alongside Imfinzi, and showed promising results in its phase 3 trial.
Patients treated with Imjudo, in combination with Imfinzi, saw a 22% reduction in the risk of death when compared with those treated with sorafenib, a commonly used oncology drug. The trial showed that 31% of patients treated with the Imjudo-Imfinzi combination were alive after three years, whereas only 20% of those treated with sorafenib were still alive after the same period of time.
The combination Imjudo-Imfinzi treatment includes taking one 300 milligram dose of Imjudo, an anti-CTLA-4 antibody, along with a 1,500 milligram dose of Imfinzi, an anti-PD-L1 antibody, then a dose of Imfinzi every four weeks. Both CTLA-4 and PD-L1 are proteins that slow the body’s immune response, binding to certain other proteins and stopping T cells from killing other cells, such as cancer cells. By stopping CTLA-4 and
PD-L1 from binding to these other proteins, the T cells are more able to kill the cancer cells.
Dave Frederickson, Executive Vice President of the Oncology Business Unit, commented: “With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to enhance the immune response against their cancer.”
FDA clears GSK’s Boostrix for use in pregnancy
The FDA has approved the use of GlaxoSmithKline’s Boostrix (Tdap) vaccine for use in the third trimester of pregnancy to prevent pertussis (whooping cough) in infants younger than two months old.
According to the Centers for Disease Control and Prevention (CDC), 4.2% of the total cases of pertussis reported in the US in 2021 were in infants younger than six months of age, and approximately 31% required hospitalisation. Boostrix is already used for active booster immunisation in children aged 10 to 18 years against tetanus, diphtheria and pertussis, and has been previously approved for use in pregnancy to protect the mother.
The determination of the effectiveness of Boostrix administered during the third trimester to prevent pertussis among infants younger than two months was based on a re-analysis of Boostrix-relevant data.
108 cases of pertussis in infants younger than two months (including four cases where the mother received Boostrix during the third trimester) and 183 control infants who didn’t have pertussis (including 18 whose mother received Boostrix in the third trimester) resulted in a preliminary estimate of Boostrix being 78% effective.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, stated: “Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at highest risk for getting pertussis and having serious complications from it. While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
Furosemide approved by FDA for patients with chronic heart failure
The FDA has approved furosemide (Furoscix) injections as an at-home treatment for patients with chronic heart failure, suffering from congestion.
It is administered through a system known as an On-Body Infuser.
According to scPharmaceuticals, heart failure affects more than six million people in the US and costs over $30bn annually, so another treatment option is hugely positive news. The new treatment is approved for treating congestion caused by fluid overload in patients with chronic heart failure who do not need hospitalisation, but have not responded to oral diuretic treatments.
Furoscix lowers fluid overload in patients to treat their congestion, and it is the only self-administered loop diuretic currently on the market. It is administered subcutaneously using a wearable, pre-programmed delivery device.
In the phase 2 trial, 51 patients were recruited, and the new treatment was compared with standard care over a 30-day period. Those treated with furosemide showed a 37% lower risk of hospitalisation from heart failure when compared to those treated with the traditional method.
John Tucker, President and Chief Executive Officer of scPharmaceuticals, said, “Congestion due to worsening heart failure is one of the most common causes of hospital admissions in patients over 65, and today’s approval of Furoscix represents an important treatment advancement for the over 7 million heart failure patients in the US that will be able to self-administer IV equivalent diuresis at home. […] We are preparing to optimise commercialisation efforts to offer Furoscix to patients in the first quarter of next year with the goal of driving rapid patient adoption to meet the needs of the $5.9bn addressable market in the US.”