FDA Panel Concerned Over Novartis’ MS Drug Safety

A Food and Drug Administration panel announced a unanimous decision on Thursday concerning the cited potential side effects of proposed Novartis AG's multiple sclerosis drugs. It claimed that the multiple sclerosis pills were safe and effective. If approved, the drug would be the first pill to treat MS.

However, the major limitation related to this drug is the insufficient data in patients with pre-existing conditions who would be rendered at high risk for developing eye and cardiovascular complications, one reviewer highlighted.

The panel of non-FDA medical experts voted 25 to 0 on questions that asked that the drug was safe and effective. However, the panel later voted 21 to 3 against a question that other drugs should be considered and experimented first.

In addition, they pointed that although FDA reviews reflect very less doubt on the drug's success in relapsing patients, yet more research was required for some of the drug's long-term side effects.

Is it speculated that the FDA would raise questions in front of the committee that whether the effect of lower doses of the drug should be studied before the agency grants its decision for approval.

Novartis’ shares were witnessed to mark a slip 0.6% in Swiss trading.