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Hereditary Hemochromatosis (HH) is the most common genetic disorder of persons of northern European extraction. The most common gene involved in causing Hereditary Hemochroma

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

tosis (HH) is the HFE gene. Most patients with hemochromatosis have two copies of the HFE mutation C282Y.

In persons of northern European extraction approximately 1 in 10 p

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ersons carries one copy of C282Y. Even one copy of C282Y can be associated with too much iron in the liver, high cholesterol, diabetes and the skin disorder porphyria cutanea

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tarda.

Approximately 1 in 200 to 300 persons of northern European extraction carry two copies of C282Y. In some northern European populations eg Ireland, Iceland and Bri

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ttany the percentage of persons carrying one copy of C282Y is higher. Predictably countries settled by northern Europeans eg Australia, South Africa and Canada have high rat

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

es of hemochromatosis.

HH is characterized by excessive absorption of dietary iron and a consequent progressive increase in total body iron stores. Iron accumulates in the

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

parenchymal cells of the liver, the heart, pancreas, anterior pituitary and skin. This accumulation of iron in body tissues causes disease.

In severe HH the disorder manife

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ts as potentially life threatening conditions such as septicaemia, cirrhosis of the liver, liver cancer, diabetes, heart failure and heart arrhythmias. Arthritis is common a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nd a severe arthritis involving numerous joints may occur. Ovarian and testicular failure secondary to iron deposition in the anterior pituitary and possibly the hypothalamu

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

s may occur. Rarely hypothyroidism may occur.

If HH is not treated liver disease may be fatal. The morbidity and mortality of HH can be reduced by early diagnosis and trea

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

tment by phlebotomy or blood letting.

There is frequently a delay between the onset of symptoms and diagnosis. This is because early symptoms such as fatigue and arthralgia

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

are non-specific.

Hereditary Hemochromatosis fits the criteria set by the World Health Organization for population screening for a disease:

1. The homozygous genotype is c

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ommon and is potentially fatal if not treated

2. The disease has a lengthy latent period with asymptomatic iron accumulation followed by a period of iron overload with rever

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

sible organ injury

3. Treatment during the latent period and the period with reversible organ injury restores the life expectancy to normal. (Treatment is safe, effective a

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

d cost effective)

4. HH can be detected by measurement of the transferrin saturation (TS).

It is very important to make an early diagnosis of HH because patients who have n

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ot developed cirrhosis and are treated by phlebotomy have a normal life expectancy.

When the diagnosis of hemochromatosis is made it is important to adjust the diet so that

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

too much iron is not being absorbed because of an improper diet. The biggest considerations are not to take medications which contain iron, consume too much alcohol or Vitami

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

n C.

The ingestion of black tea has been shown to decrease the absorption of iron. African tea which is becoming popular may contain iron so too much should not be consumed

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

. Don’t take milk thistle which has often been touted as good for the liver as it can cause severe problems in those with hemochromatosis. Don’t eat raw shellfish. They may

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

be contaminated with Vibrio vulnificans which thrives in an iron rich environment. There have been fatalities in the northern hemisphere. Cooking inactivates this organism

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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