(Alliance News) - AstraZeneca PLC on Monday said Enhertu has been granted breakthrough therapy designation in the US, while Bevespi Aerosphere was approved in China.
The FTSE 100-listed drugmaker said Enhertu was developed for the treatment of patients with metastatic non-small cell lung cancer.
Astra explained that non-small cell lung cancer is the most common type of lung cancer, and prognosis is particularly poor for patients with metastatic disease as only about 6% to 10% will be alive five years after diagnosis.
"Today's news is very welcome as we continue to evaluate the potential of Enhertu to help patients with this devastating type of lung cancer," said Jose Baselga, executive vice president Of Astra's Oncology Research & Development division.
Turning to Bevespi Aerosphere, Astra said it has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
The approval by the National Medical Products Administration was based on positive results from the phase III Pinnacle 4 trial in which Bevespi Aerosphere demonstrated a statistically significant improvement in lung function, the company said.
"The use of maintenance combination therapies in China is increasing year-on-year and the approval of Bevespi Aerosphere offers an important new treatment and choice of inhaler for patients, particularly those with limited lung function and advanced age who may benefit from using a pressurised metered-dose inhaler," said Mene Pangalos, executive vice president at Astra's BioPharmaceuticals Research & Development.
Bevespi Aerosphere is already approved in the US, EU, Japan and other countries for the long-term maintenance treatment of moderate to very severe chronic obstructive pulmonary disease.
Shares in Astra were up 1.8% at 8,826.00 pence each in London on Monday morning.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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