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Last-minute drive at FDA added 6 new drug approvals

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By John Carroll and Ryan McBride

The push to a record rate of new drug approvals required a big fourth-quarter effort on the part of the FDA. In December the agency handed out 8 new drug OKs, and six of them came in the waning days of 2012, after FierceBiotech had begun its official publishing break for the holidays. Our readers who regularly check our website know that we kept up with the news online. But for everyone else, here's a roundup of the regulatory actions you may have missed:

  • On the last day of 2012 the FDA OK'd Salix Pharmaceuticals' crofelemer for use in treating HIV-related diarrhea. The drug, to be marketed as Fulyzaq, is derived from the red sap of the Croton lechleri plant, making this the second botanical drug ever approved by the agency. Analysts don't expect the drug to be a big earner. A Bloomberg report in September noted that the average sales estimate for 2014 was only $33 million. But the agency notes that HIV/AIDS patients often suffer from diarrhea, forcing them to switch their treatments, making this a significant advance for that patient population. And Salix ($SLXP) has counted on Fulyzaq to broaden its product line. Story
  • Another drug to barely make the end-of-year deadline was Johnson & Johnson's bedaquiline, the first new treatment for drug-resistant tuberculosis in four decades. The approval was based on midstage data after J&J ($JNJ) made its case that the urgent need for a new TB therapy warranted an OK ahead of Phase III results. J&J will sell the drug as Sirturo, part of a combination therapy that will now be available as a last-ditch treatment for patients who have failed standard remedies. The FDA handed out the accelerated approval based on rules that allow the agency to green-light a therapy on efficacy data based on a surrogate endpoint. Report
  • The big approval in this last wave of regulatory nods was reserved for Eliquis, the clot buster from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE), which garnered the agency's stamp for use in certain patients with atrial fibrillation. Bristol and Pfizer--which have suffered from generic competition to the big-selling meds Plavix and Lipitor, respectively--have now won approval for the most lucrative use of the drug in the world's top healthcare market. The FDA sanctioned the bloodthinner for reducing risk of stroke and blood clots in patients with nonvalvular atrial fibrillation, saying that the drug shouldn't be used in patients with artificial heart valves or defective heart valves. Report
  • Alexza Pharmaceuticals ($ALXA) won an early Christmas present when the FDA handed out a long-sought approval for an antipsychotic drug called Adasuve. Wasting no time, the company plans to push the inhaled med onto the U.S. market early in the first quarter of 2013. U.S. regulators stamped an approval of Alexza's inhaled version of the antipsychotic drug loxapine for adults struck with agitation linked to schizophrenia or bipolar disorder. The approval comes with warnings about serious adverse events such as potentially lethal bronchospasms and increased risk of death in elders with dementia-related psychosis. Report
  • The FDA also approved Aegerion's ($AEGR) new drug for homozygous familial hypercholesterolemia on Christmas eve, clearing a path to begin commercialization as the biotech comes to a major turning point. Lomitapide will now hit the market as Juxtapid featuring a boxed warning about the distinct threat of liver toxicity. "We are excited that Juxtapid will become a new treatment option for patients with HoFH," said Marc Beer, the CEO at Aegerion. "The approval of our first product also marks an important corporate milestone for Aegerion and reflects our commitment to help patients in need." Story
  • And near the end of the day on December 21 the FDA stamped an approval on NPS Pharmaceuticals' ($NPSP) Gattex for treating patients with short bowel syndrome. The approval sets the stage for the U.S. launch of the company's lead drug. The sanctioning of Gattex isn't a big surprise. FDA advisers unanimously endorsed the drug, which helps patients with the syndrome reduce their dependence on IV feeding, for approval in October. And most of them backed the REMS plan from the company to monitor cancer and other risks associated with the therapy. Article

Slideshow: FDA Approvals of 2012