AstraZeneca plc (ADR)(NYSE:AZN) Durvalumab Nabs Its First FDA Approval

AstraZeneca plc (ADR) (NYSE:AZN)

Durvalumab, a key immunotherapy drug from AstraZeneca plc (ADR)(NYSE:AZN) has been sanctioned by the Food and Drug Administration in the treatment of advanced bladder cancer. Patients with locally advanced or metastatic urothelial carcinoma have everything to benefit from the approval of the inhibitor Imfinzi, which is the first of its kind.

Story continues below

The approval, which gives the British company a new milestone, was based on a trial of 182 patients whose disease had advanced after previous platinum-containing chemotherapy failed.

Durvalumab’s big commercial opportunity

The approval marks the first commercial green light for the pharma giant, which now enters the advanced bladder cancer space in the third position. The green light is expected to introduce the bladder cancer drug into a commercial opportunity that has not been well exploited. This somewhat also contributed to the accelerated approval.

AstraZeneca’s Chief Executive Pascal Soriot says, “This first approval for Imfinzi is an important milestone in our return to growth.” The company is optimistic about making billions from the product despite the competition threat from the likes of Merck & Co., Inc.(NYSE:MRK), which is also pursuing a bladder cancer nod for its Keytruda.

Higher ambitions

AstraZeneca was initially a very strong market player before it lost its patent on older blockbuster products the likes of Nexium and cholesterol pill Crestor. However, it is of the view that new cancer drugs will play a significant role in reviving its market position despite the presence of its rivals Bristol-Myers Squibb Co (NYSE:BMY) and Roche. The two have already obtained an approval of their immunotherapies.

Nonetheless, the British pharma giant is working on other ambitions, which may help give it a better presence. It is testing Imfinzi not only as a monotherapy but also in tandem with tremelimumab. The price of the new drug may be higher than that of its rivals given that it will cost around $15,000 a month but nevertheless it is said to have the potential of longer-lasting efficacy.

In the meantime, AstraZeneca will be required to carry out trials to confirm how beneficial the drug is. Meanwhile, AstraZeneca’s stock closed at $30.27 witnessing an increase of $0.02 or 0.07%.

An ad to help with our costs