Takeda’s bet on Shire begins to pay off; key drug bags FDA approval

By PharmaCompass

2018-08-30

Impressions: 172 Article

Just a few months after Takeda announced its US$ 62 billion acquisition of Dublin-based Shire, the Irish drug company got FDA’s marketing approval for lanadelumab – a monoclonal antibody that showed outstanding phase III results for a rare hereditary disease following a priority review by the agency.

Lanadelumab is a treatment designed for patients aged 12 and above with hereditary angioedema (HAE) — a rare disease affecting one in 50,000 men and women with symptoms such as recurrent, unpredictable episodes of severe swelling, most often in the stomach, limbs, face and throat.

In a pivotal 26-week Phase III clinical trial, the HELP (Hereditary Angioedema Long-term Prophylaxis) Study, which included 125 patients, 27 patients receiving 300 mg lanadelumab once in every two weeks saw an 87 percent reduction in the number of monthly HAE attacks when compared with a placebo. A little less than half the patients who received 300 mg of the Shire drug every two weeks had zero HAE attacks compared to the placebo.

Analysts expect the drug to bring in US$ 1.3 billion and Takhzyro dominated a chart put together by GlobalData on the future sales potential for Shire’s product pipeline.

The FDA also approved European pharmaceutical company, Dompé farmaceutici SpA’s treatment for neurotrophic keratitis — a rare and progressive eye disease which can lead to corneal scarring and vision loss.

The ophthalmic solution, Oxervate (cenegermin-bkbj), is a recombinant human nerve growth factor (rhNGF) that resembles the nerve growth factor of the human body and acts directly on corneal epithelial cells to stimulate their growth and survival.

The regenerative potential of NGF was discovered by Nobel-prize winning scientists, but its therapeutic potential was not realized in ophthalmology until Dompé's research and development team based in L'Aquila, Italy, created cenegermin-bkbj, a recombinant version of the human NGF, through a unique development process.

Oxervate’s approval from the FDA came a year after it won a nod in Europe. Dompé plans to roll out the drug in early 2019, according to sources quoted by FiercePharma.

Neurotrophic keratitis has an incidence rate of five in 10,000 individuals.

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