Asthma and COPD Patients Score With Generic Advair Diskus FDA Approval

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More and more branded drugs seem to be facing generic competition. The impact might not be so positive for Big Pharma giants, but this can be a serious victory for consumers and patients who are in need of lower drug prices now and in the future. The U.S. Food and Drug Administration (FDA) has just approved the first generic of Advair Diskus as a twice-daily treatment of asthma in patients aged 4 years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Mylan N.V. (NASDAQ: MYL) obtained approval to market its generic inhaler in three strengths. The Advair Diskus is marketed by GlaxoSmithKline PLC (NYSE: GSK), and this is far from being a small drug. Advair sales had been declining over time to about $3.1 billion globally in 2017, but the sales were over $5 billion in 2013. The website Statista showed that U.S. Advair sales were $1.6 billion in 2017.

Chronic lung diseases are serious issues for America and elsewhere. In the United States alone, over 26 million people are known to have asthma, and about 7 million of them are children. COPD is a progressive lung disease that makes it hard to breathe and may become worse over time, and sadly there is no cure. COPD can become debilitating and fatal over time. According to the American Lung Association, COPD is the third leading cause of death in the United States and more than 11 million people have been diagnosed with COPD. Sadly, the group warned that millions more may have the disease without even knowing it.

24/7 Wall St. went back to a press release from early 2018 and GlaxoSmithKline had already been warning about the introduction of generic competition at that time. The company warned then that its adjusted earnings growth would be impacted by a number of factors — “including, in particular, uncertainties relating to the timing and extent of potential generic competition to Advair in the US.”

GSK further noted in 2018 that it had been seeing increased pricing and competitive pressures in the US inhaled respiratory market and that it was already expecting a decline in 2018 US Advair sales of around 30%. Again, this is no small issue for GSK. Even at the start of 2018, GSK noted:

In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, the Group expects full year 2018 US Advair sales of around £750 million at CER (US$1.30/£1), with Adjusted EPS flat to down 3% at CER.

Mylan showed in its FDA approval on Wednesday that the approved strengths are as follows: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg. A quote from the FDA’s Center for Drug Evaluation and Research said:

Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives. People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.

A large stock market rally likely skewed some of the market moves in key stocks on Wednesday. That said, Mylan shares closed up 7.1% at $30.82 with a market cap of almost $16 billion.

GSK’s American depositary shares closed down one cent at $38.71, with a $94 billion market cap after a late day drop after the generic news broke.