The FDA is taking a look at a fresh set of standards that demand new tests to determine if diabetes drugs elevate heart risks. Safety advocates sounded approving after seeing the FDA draft guidance that came out at the end of February. But investors have proven to be less thrilled. In one case, they sent the shares of Amylin down to a 30-month low after determining that the new rules could significantly delay final approval of a new drug.
"It is setting the stage for some harder times for diabetes drugs," says researcher Clifford Rosen. According to Rosen the message to drug companies is clear: "Be careful" to remember that blood sugar alone will not warrant an automatic approval.
- check out the report from Forbes