Pharmalot… Pharmalittle… Good Evening
Make a commentBy Ed Silverman // March 18th, 2008 // 6:05 pm
Another busy day draws to a close. And so the time has come for us to check on how the short people are faring with their after-school sports and curl up in front of the telly with the shortest one of all. Of course, first we must feed the dog. Meanwhile, we hope your day was productive and you do something fun this evening…
The FDA is warning that Spiriva, a drug for COPD, or chronic obstructive pulmonary disease, which is marketed jointly Pfizer and Boehringer Ingelheim, may increase the risk of a stroke. In a statement on its web site, the FDA says a preliminary analysis by Boehringer of about 13,500 patients from 29 clinical studies found that the risk of a stroke was 8 in 1,000 patients taking the inhaled drug, compared with 6 in 1,000 who took a placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period. However, the agency has not confirmed the results.
Glaxo’s Tyverb breast cancer drug was sent back to a European regulatory panel after new data showed the medicine may raise the risk of liver damage, slowing final approval, Bloomberg News reports. The European Commission returned the application to the region’s health-care regulator for further discussion next month. An agency committee recommended approval of Tyverb following a review in December. The commission was expected to issue a final decision on the breast cancer drug between Feb. 22 and March 8, according to Glaxo.
Fred Hassan, Schering-Plough’s ceo, expressed confidence in several late-stage drugs being developed, but offered tepid enthusiasm for the asenapine treatment for schizophrenia during a Wall Street conference, Reuters writes. The schizophrenia drug was one of two meds that were obtained as part of the $14.5 billion purchase last year of Organon Biosciences. Some analysts questioned the value of asenapine because Pfizer once held rights, but relinquished them to Organon. Moreover, clinical trial data didn’t appear to give asenapine a clear lead over existing meds.
The FDA issued an approvable letter for antibiotic that Johnson & Johnson and Basilea Pharmaceutica hoped to sell to treat deadly drug-resistant skin infections, Bloomberg News reports. But the agency wants more time to inspect study locations and to review data on the use of the med for diabetic foot infections. As a result, it remains unclear whether new studies will be needed or how long the review will take. The drug is designed for complicated skin infections, including drug-resistant MRSA, or methicillin-resistant staphylococcus aureus.