Five things for pharma marketers to know: Friday, August 15
UK drug-cost watchdog NICE said today it would provisionally back hepatitis C pill Sovaldi for chronically ill patients—although at a reduced price from what's been seen in the US ($58,400 vs. $84,000—a 30% discount) for a 12-week course of treatment, Reuters reported. That wasn't the only appearance of Sovaldi in the news today, however. New Haven, CT, drugmaker Achillion announced interim results of an ongoing Phase-II trial with sofosbuvir and its NS5A inhibitor ACH-3102 in genotype 1 patients (the most common subset of the disease). The trial boasted strong results with 12 out of 12 patients enrolled showing undetectable levels of the virus after four weeks of treatment.
FDA has approved Roche oncology treatment Avastin for use in late-stage, aggressive cervical cancer, the drugmaker reported. A study published in NEJM in February showed that the drug plus chemotherapy added four months of survival among those with advanced stages of the disease. Avastin also received a priority review in the category this past July. In additional to cervical cancer, Avastin is currently indicated for metastatic colorectal cancer in first- and second-line indications, non-squamous non-small cell lung cancer, gliobastoma and metastatic kidney cancer.
The Ebola outbreak is worse than initially expected. Bloomberg reports that the World Health Organization's staff has found that the number of reported deaths and cases “vastly underestimate the magnitude of the outbreak.” There is no cure for the disease, and experimental drugs are being tested on humans, an effort the WHO declared to be ethical earlier this month. The disease has spread to Sierra Leone, Guinea, Liberia and Nigeria. The Wall Street Journal reports that eight Ebola victims in Nigeria will be the test subjects of an experimental drug called Nano Silver, which was developed by a Nigerian scientist. Several Liberians have received Zmapp. Efforts to contain the infection have included geographic quarantines, and concerns include the rising death toll and the outbreak's economic impact. Bloomberg reports that Korean Air Lines will stop flights to Kenya August 20 after the WHO declared the area high-risk, despite the lack of diagnosed cases. The site also says Deutsche Lufthansa and Air France are among airlines which are maintaining flights but “screening departing customers more carefully.” Teneo Intelligence says the outbreak could cost 2 percentage points of economic growth in three of the countries.
An FDA advisory panel voted 10-3 in favor of Boehringer Ingelheim's experimental COPD treatment, which will be known as Spiriva Respimat. The once-a-day maintenance medication is for bronchospasm associated with COPD. The company said in a statement that an FDA approval—the panel's vote just shows where it sits, but does not speed items onto pharmacy shelves—“would provide physicians and their patients with a choice between a mist and a dry powder inhaler for tiotropium.”
Accelerated drug-review processes are good news for pharmaceutical manufacturers and their sales reps, but an assessment published in Health Affairs indicates that speedy reviews through channels such as the FDA's Priority Review program are linked to a spike in black-box warnings associated with these same drugs. Medscape Medical News reports that researchers supported their findings by comparing and contrasting approvals of 748 drugs between 1975 and 2009. Their findings: half of the black-box warnings were added within 12 years of approval, and around one-half of withdrawals (these have also jumped) happened within five years of the regulatory green light. Drugs approved after enactment of PDUFA, which enabled FDA to collect user fees in exchange for faster review, were found to be more likely to be withdrawn or to receive a black box warning, Medscape noted.