The FDA approved the first generics for Otsuka’s Abilify (aripiprazole), granting four generic drugmakers approval to market the treatment for schizophrenia and bipolar disorder. Teva, Torrent, Hetero and Alembic will now be able to sell generic aripiprazole in multiple strengths and doses. Branded Abilify is sold by Bristol-Myers Squibb in the US. The drug brought in total sales of $554 million in the first quarter of 2015.
Mylan upped the ante for Perrigo, offering $34 billion—up from $31 billion last week— which Perrigo promptly rejected again. A combined Mylan-Perrigo would control 25% of the US generic drug market. Perrigo acquired Dublin-based Elan in 2013 for $8.6 billion in a tax-saving redomicile maneuver, while Mylan acquired a portion of Abbott’s generic business in July for $5.3 billion. Mylan is currently fending off a takeover from Teva.
The standard cure regimen for new hepatitis-C drugs, known as sustained virologic response over 12 weeks, may now be too long in the increasingly competitive category, Bloomberg surmised. The news service, citing a hepatologist in California, wrote that “companies will have to demonstrate that the drugs have a sustained effect in those tougher patient groups at [a] quicker pace to win over regulators.” A spokesperson for Achillion, which is currently evaluating its own HCV treatment to be used in combination with Gilead Sciences’ drugs, told Bloomberg that next-generation regimens have to be simpler and shorter.
Drugmakers, too, are getting in on the gluten-free fad now that studies find that 1% of the population has the disease. The race to develop treatments for celiac disease is heating up, The New York Times wrote. The Gray Lady said major pharma companies like AbbVie and GlaxoSmithKline along with Sitari, a venture capital–backed drugmaker, are aiming to find a drug that can stymie the disease’s symptoms. The FDA also recently conducted a public workshop to develop drug targets and discuss how to measure the effectiveness of celiac disease drugs in trials.
The FDA denied approval once again to Merck’s Bridion, a treatment to reverse the effects of muscle relaxants used in surgery. The agency cited hypersensitivity concerns, including allergic reactions, for the drug in its denial. The drug is currently sold in more than 60 countries, according to Reuters.