Teva’s QVAR® RediHaler™ Inhaler Wins FDA Approval

  • 2017-08-12

Recently, US Food and Drug Administration (FDA) has approved the QVAR RediHaler inhaler (with main active ingredient of beclomethasone dipropionate HFA, and for the maintenance treatment of patients with asthma) of Teva Pharmaceutical Industries Ltd. (Teva).

The QVAR RediHaler contains the same active drug ingredient with QVAR (beclomethasone dipropionate HFA), with a different mode of delivery. In addition, QVAR RediHaler is designed to be used without shaking or priming.

“It’s important that we uncover new opportunities to take longstanding, clinically effective medications, such as QVAR, and incorporate them into device technologies that may help address key ongoing issues for patients, including inhaler technique,” said Dr. Tushar Shah, Teva’s head of late-stage development. ”

Teva plans to launch the QVAR RediHaler in the first quarter of 2018. It will discontinue sales of the conventional metered-dose inhalers QVAR MDI upon official marketing of the new inhaler. QVAR MDI was approved by FDA in May 2014 to be used in patients 5 years of age and older with asthma for long-term treatment.

Teva, a global generic drug giant, suffered a slump of stock price last week, and reported the second quarter results on August 3, saying that the earnings per share and revenue is not as good as anticipated. The revenue of TEVA in the second quarter reached $5.69 billion, with a YOY growth of 12.9%, $40 million lower than anticipated; in the second quarter, TEVA suffered an impairment of $6.1 billion, resulting in a net profit attributable to parent company of $-5.97 billion. The net profit in the first half year of 2017 was $130 million excluding the asset impairment, $254 million less than the net profit in the same term last year.

The stock marketability of TEVA reflects the change of US generic drug industry; Mylan, a benchmarking enterprise of generic drug, also suffered stock drop. Upon taking office, Trump government has attacked the high drug price many times and plans to reform the drug. FDA also speeds up the generic drug approval to lower the drug price by enhancing competitiveness, the European and American traditional generic drug enterprises are facing with both price and sales stress.

Since 2016, FDA has improved it approval efficiency, and approved 835 drug instructions throughout the year, hitting a new high. Scott Gottlieb, FDA commissioner, appointed in May 2017, advocated speed up the approval of generic drug to break the absolute monopoly of Reference Listed Drug, with the expectation to lower the drug price by introducing competition. FDA’s speeding up of the approval provides great opportunity to China’s pharmaceutical companies in the internationalization process, the drug registration application of China’s enterprises is expected to be approved faster.

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