Alexion issued new FDA Form 483 for Rhode Island plant

The FDA has again raised issues at an Alexion plant that three years ago was issued a warning letter. The facility is where Alexion manufactures what has been deemed the world’s most expensive drug, Soliris.

Alexion ($ALXN) filed an 8-K with the SEC on Monday saying that the FDA issued a Form 483 with three observations following a recent inspection of the Smithfield, RI, manufacturing plant, a facility with a history of manufacturing lapses. The Cheshire, CT-based company said the observations related to “closure of certain investigations, validation of surface sampling methods, and monitoring of water systems.”

It said none of the observations were designated as a repeat observations and that it will work “diligently to address the observations.”

Alexion continues to manufacture Soliris at the plant and said that it doesn’t anticipate that supply will be interrupted for the orphan drug. Soliris, which can run up to $400,000 a year, treats the life-threatening blood disorder paroxysmal nocturnal hemoglobinuria, a disease that only affects about 8,000 Americans. In its Q2 earnings release July 28, the drugmaker reported second-quarter revenues of Soliris were up 10% to $701 million on a 15% growth in volume.

In 2013, Alexion was issued a warning letter for the Rhode Island plant after the FDA found the company had not thoroughly investigated “bacterial contamination of certain batches,” as well as other cGMP issues. In that case, the FDA noted some repeat problems from a visit the year before. It later had problems with a contractor filler and had to recall some lots of Soliris. Then, in 2014, the Rhode Island plant was cited with more observations in a follow-up inspection.

In the filing Monday, Alexion said that it has continued to work on its quality program.

Image: Soliris

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Teva recalls antibiotic made at banned plant in Hungary

Aug 8, 2016

When the FDA put Teva’s sterile manufacturing site in Hungary on its import alert list in May, it banned all but two of its products, cancer treatment bleomycin and antibiotic amikacin. The exclusions didn’t mean the FDA didn’t have some concerns with those drugs, and now the drugmaker is expanding a recall of the antibiotic.

Teva ($TEVA) said last week it was recalling 7 additional lots of amikacin sulfate due to the potential for the presence of glass particulate, which it said could cause reactions from swelling to blood clots. It said it had not received any reports of adverse reactions to the product.  

 

When Teva first recalled a lot of the antibiotic in March, it indicated that it was manufactured at its plant in Gödöllő, Hungary. The company had temporarily halted production at the plant in January after an inspection cited it with a number of shortcomings. The agency followed that up with the ban in May.

After the FDA banned products from the Hungary plant, Teva said it was “working around the clock to restart manufacturing operations as soon as possible, and are working cooperatively with regulatory authorities to minimize any potential impact on product availability.”

That impact was particularly hard on Hungary, which lost access to about 200 drugs as a result of the shutdown. The Hungary drug regulator said it was getting weekly updates from Teva about the situation so that it could avoid shortages, particularly of cancer and morphine drugs.