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AZ’s benralizumab; Sanofi, Regeneron set; Nordisk preps; European countries offer

May 23, 2017

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AstraZeneca’s new benralizumab helps severe asthma patients cut back on steroids

AstraZeneca’s respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed. Dubbed Zonda, the phase 3 trial found that patients taking benralizumab were more than four times more likely to reduce oral steroid use than those who received a placebo. And 52% of eligible patients were able to completely discontinue the pills, investigators reported, while still seeing reductions in asthma exacerbations. In addition to cutting back on steroids, patients on benralizumab saw a 70% reduction in the rate of exacerbations compared to those on placebo. The respiratory biologic was associated with a 93% reduction in exacerbations that required emergency room visits. AZ unveiled the new data at the American Thoracic Society conference in Washington, D.C. The findings were simultaneously published in the New England Journal of Medicine. Benralizumab has an FDA action date during the fourth quarter of 2017. Until then, AZ is preparing to be ready in the beginning of next year to launch this product.

Sanofi, Regeneron set Kevzara up for tough RA turf battle with $39K list price

Sanofi and Regeneron just added another building block to a nascent immunology franchise expected to bring in $5 billion or more by 2022. But to get there, their new Kevzara will have to go up against a host of other rheumatoid arthritis meds already on the market—and a few still on their way. One way Kevzara can do that? A lower price, according to doctors surveyed by GlobalData analysts. And Kevzara will have a list price of $39,000 per year, the companies say, 30% lower than the two most widely used TNF-alpha drugs, which will be among its chief competitors. Kevzara’s nod comes more than six months after the FDA turned back the drug on manufacturing problems at a Sanofi plant where drugs are filled and finished. The two companies worked with the agency to fix them, and after a successful inspection earlier this year, the Kevzara approval was widely expected. Kevzara (sarilumab) is Sanofi and Regeneron’s second entry into the immunology field, after the approval of Dupixent, a treatment for severe eczema, in March.

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Novo Nordisk preps Saxenda sales drive in Latin America after its ‘phenomenal’ Q1

Novo Nordisk, facing more pressure than ever in the U.S., is revving up for a push into Latin America with its obesity drug Saxenda, hoping to put already-promising sales into a higher gear. The drug maker plans to expand its capacity in Latin America and step up its efforts in the obesity market there. The Danish drugmaker sees a particular opportunity in Mexico. Saxenda generated sales of $81 million for the first quarter, including $10.5 million in Latin America. Novo first launched Saxenda in 2015 in an effort to diversify beyond diabetes, a business that has had trouble growing lately due to competitive pressures in the U.S. The Danish drugmaker rolled its obesity shot out at $1,000 per month and said it has “blockbuster potential.” In Latin America, Doustdar said he believes Novo can expand the entire obesity market as well as capture a share of it with Saxenda.

European countries offer goodies in bid to win EMA after Brexit

Even before European officials present the groundwork for relocating the bloc’s drug regulator, a fight has emerged between countries vying for the economic lift and status that come with hosting the authority, using perks like child care as ammo. Some 20 countries in Europe hope to host the European Medicines Agency after the U.K.’s vote to leave the union last summer. And even though the EU hasn’t announced its official criteria for the move, the countries aren’t hesitating to make their case by showcasing local lifestyle perks and more. Countries in Europe are offering language lessons, local scenery and child care as they push to win the EMA, according to the news service. They’re seeking to attract an agency that could bring an economic lift worth an estimated €1 billion and employs about 900 experts.