Shire Lifitegrast dry eye drug not approved by FDA, even as maker bids for Baxalta

Lifitegrast, a chronic dry eye syndrome drug manufactured by Irish drugmaker Shire Plc has failed to win approval from the US Food and Drug Administration (FDA), and this development has affected its bid to merge with US rival Baxalta to enable it become the leading specialist in rare conditions.

Shire disclosed that FDA requested for additional clinical study before the dry eye drug could be considered for approval, even though market analysts had predicted that lifitegrast could generate about $1 billion every year in global sales.

Shire revealed that FDA dispatched a letter known as complete response to it, and such letters are sent to let a drug developer understand that a marketing application would not be approved just yet in its present form.

It is possible that the development will impact negatively on Shire’s stocks, even though the Irish-based company’s shares have lost about one-fifth of its value since its all-share offer to buy Baxalta was announced early August. Baxalta has a value of about $30 billion at this time.

Shire develops some of the most expensive drugs in the world, but these are largely for treatments of rare diseases. But it revealed the FDA wanted to have more product quality information and also obtain data from more clinical trial before approving the drug.

Since its bid for Baxalta has attracted unpleasant reactions, it is possible that Shire might turn attention Radius Health Inc. because of its manageable size and because it has a market value that is less than $3 billion naira.

Shire concluded a Phase III trial for lifitegrast in response to the FDA’s letter, but these data might only be released as the year comes to an end or before the first quarter of next year with submission made to the FDA.

“We will work quickly to address the FDA’s requests related to lifitegrast, as we are committed to delivering a new prescription treatment option for the 29 million adults in the U.S. living with the symptoms of this chronic and progressive disease,” Shire’s research head Philip Vickers said in a statement.

Patients experience blurred vision and itching or burning eye sensation when they suffer from chronic dry eye syndrome, and this causes the tear-producing glands in the eyes to experience dryness.