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US regulators grant orphan drug status to AstraZeneca’s Imfinzi cancer drug

Imfinzi recently showed in a late-stage study that, when combined with chemotherapy, it had a “clinically meaningful” effect on overall survival

lung cancer
Orphan drug designation has several benefits for the company making the treatment

The US Food and Drug Administration has granted Orphan Drug Designation to AstraZeneca PLC’s (LON:AZN) Imfinzi drug for the treatment of small cell lung cancer.

ODD is awarded to drugs which are intended to treat rare diseases that affect relatively small patient populations – fewer than 200,000 in the US.

The status comes with a number of benefits for drugmakers, such as tax credits and reduced fees, while regulators tend to make it a bit easier for the treatments to win approval.

READ: Astra gets two positive opinions from European Medicines Agency committees

Imfinzi’s orphan drug designation comes after it impressed in a recent phase III trial which tested it in combination with standard chemotherapy.

The full data is due to be presented shortly, but AstraZeneca confirmed last month that the trial had achieved its primary endpoint, showing that the combo of Imfinzi and chemo delivered a “statistically-significant and clinically-meaningful” improvement in overall survival compared to standard-of-care chemotherapy alone

“This Orphan Drug Designation comes on the heels of positive results from the phase III CASPIAN trial, which is the first trial to offer the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer,” said José Baselga, executive vice president, R&D oncology.

“We are eager to expand treatment options for patients facing such a devastating diagnosis and look forward to working with regulatory authorities to bring forward new options as soon as possible.”

Analysts waiting on full readout

Analysts at Shore Capital estimate that there are 34,500 cases of small cell lung cancer every year in the US, implying a market worth up to US$2bn.

AstraZeneca has some work to do if it wants to take a large slice of that, though, given that Roche’s Tecentriq was recently approved for the same indication after showing it could reduce the risk of death by around 30%.

“As such, we will have to wait and see the full data from CASPIAN, but note Astra’s use of “clinically-meaningful” in the description of its results,” said the Shore Cap chin scratchers.

“We also believe Imfinzi’s extensive use in the Stage III NSCLC setting would be a competitive advantage given its brand equity and awareness amongst physicians.”

Astra shares were down 1% to 6,318p on Friday morning.

Quick facts: AstraZeneca

Price: 6803 GBX

Market: LSE
Market Cap: £89.25 billion
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