What You Missed From The FDA Last Week—August 25-29, 2014

Pifzer, GSK HIV Combo Drug Approved

GSK’s and Pfizer’s joint venture ViiV Healthcare was awarded an FDA approval for its combination HIV drug, Triumeq. The treatment is a combination of three different drugs: GSK’s Tivicay, abacavir, and lamivudine. Triumeq is the second single-dose HIV treatment with an integrase inhibitor to hit the market since Gilead Sciences’ $539 million player, Stribild. Tivicay, one of the key components of the Triumeq, is expected to his $1 billion in sales by 2016, reaching a high of $2.2 billion in 2018, Bloomberg analysts say. Tivicay sales are also expected to bolster Triumeq as well, since the drug is based off of Tivicay.

Iroko Pharma’s Zorvolex Awarded FDA Approval

Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), received FDA approval last week for those suffering from osteoarthritis pain. This follows a 2013 approval from the FDA for the treatment of mild to moderate acute pain in adults. The drug, which contains submicron particles of diclofenac, is a quickly dissolving capsule. The drug was investigated in a 12 week trial enrolling 305 patients with hip or knee osteoarthritis. There was also a 12 month open-label safety study that enrolled 602 patients.

Strides Arcolab Buspirone Tablets Get FDA Thumbs Up

The FDA approved Buspirone Hydrochloride tablets, indicated for anxiety disorders and short-term anxiety symptom relief, in 5 mg, 10 mg, 15 mg, and 30 mg dosages. The product will be manufactured in Strides’ oral dosage facility in Bangalore and will be marketed in the U.S. by Strides Arcolab. Generic Buspirone tablets clocked in at $65 million in the U.S. market last year.

GSK’s Eltrombopag Given Nod For Additional Indication

GSK’s Promacta (eltrombopag) received approval for an addition indication last week. Patients with severe aplastic anemia (SAA) that have not seen progress by using immunosuppressive therapy (IST) now have another treatment option in Promacta. The drug also has indications in chronic immune thrombocytopenia (ITP) and chronic hepatitis C. The drug was the focus of a 43-person NIH Phase 2 study, which demonstrated that patients with insufficient response to previous treatment experienced a hematologic response upon treatment with eltrombopag.

Pfizer Vaccine Earns Fast Track Designation

Pfizer’s investigational vaccine candidate for Clostridium difficile was fast tracked by the FDA to bring a potential treatment option closer to patients dealing with the dangerous and difficult-to-treat illness. The vaccine is currently in Phase 2 clinical development. There are no vaccines available in the market today to prevent the infection-associated disease, which affects upwards of 250,000 and causes 14,000 deaths per year. 

Amgen CHF Drug Awarded Priority Review

Ivabradine, indicated for chronic heart failure (CHF), received priority review designation last week. The oral drug was the subject of a global clinical trial program known as SHIFT, which examined the drug’s effect compared to placebo and standard-of-care therapies in more than 6,500 patients. The drug, which inhibits the If— or “funny”— current in the sinoatrial node and slows the heart rate, was previously granted fast-track designation by the FDA in April 2014.

Pharma Talking Points

An article in the Albany Business Review says that a former FDA official, Andrew von Eschenbach, has made the argument that the FDA is holding back instead of encouraging the creation of new drugs. As trials are becoming larger and more expensive, Eschenbach says that the agency is becoming too “risk-averse” as pharma scientists ramp up their research and discoveries.  Eschenbach also poses the arguments that the FDA needs to enable drugs to be approved conditionally following analysis of biomarkers and that there needs to be a better approval process for products combining drugs with medical devices or diagnostic tests.

The FDA has released its fourth draft guidance under the 2012 Generic Drug User Fee Act which outlines how generic drug companies can submit information requests from the agency, Regulatory Affairs Professionals Society (RAPS) reports. The guidance addresses the rate at which the FDA expects to respond to controlled correspondence letters over the next three years, as well as highlights some of the potential delays that may occur and how the FDA plans to respond to these delays.

Following the release of its plan to ensure the participation of women and minorities in clinical trials, the FDA was met with what the Wall Street Journal blog calls “faint praise,” in particular from several women’s advocacy groups. According to the blog, advocacy groups claimed that the plan does not sufficiently require drug makers to include specific demographic information in a product’s labeling. The main concern is that there is not enough incentive for the industry to continue to recruit more diverse groups. One proposed solution was that the FDA needs to avoid approving drugs and devices that were not sufficiently tested in these demographic subgroups.